PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84)


Device Classification Name

radioimmunoassay, parathyroid hormone

510(k) Number K022472
Device Name PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84)
Original Applicant
NICHOLS INSTITUTE DIAGNOSTICS
1311 calle batido
san clemente, 
CA 
92673

Original Contact jimmy wong
Regulation Number 862.1545
Classification Product Code
CEW  
Date Received 07/26/2002
Decision Date 10/09/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls