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510(k) K820253

SIMUL-FER SERUM IRON TEST KIT by Diagnostic Reagents, Inc. — Product Code JJA

K820253 is an FDA 510(k) premarket notification submitted by Diagnostic Reagents, Inc. for the device "SIMUL-FER SERUM IRON TEST KIT". The FDA issued a decision of Substantially Equivalent on May 12, 1982. The device falls under product code JJA (Radio-Labeled Iron Method, Iron (Non-Heme)), a Class I device regulated under 21 CFR 862.1410. Diagnostic Reagents, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1982
Date Received
January 29, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radio-Labeled Iron Method, Iron (Non-Heme)
Device Class
Class I
Regulation Number
862.1410
Review Panel
CH
Submission Type

Other clearances by Diagnostic Reagents, Inc.

  • K983268 — MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY (November 18, 1998)
  • K983812 — NAPA EIA ASSAY (November 16, 1998)
  • K983323 — DIGOXIN IMMUNOASSAY (November 12, 1998)
  • K983280 — VANCOMYCIN EIA ASSAY (November 6, 1998)
  • K983159 — DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS (November 5, 1998)
  • K973102 — LIDOCAINE EIA ASSAY (September 12, 1997)
  • K972835 — 50NG/ML COCAINE METABOLITE CALIBRATOR (August 28, 1997)
  • K972526 — METHADONE EIA ASSAY (August 4, 1997)
  • K964212 — QUINIDINE ENZYME IMMUNOASSAY (December 18, 1996)
  • K963835 — DIGOXIN ENZYME IMMUNOASSAY (December 10, 1996)

Other clearances for product code JJA

  • K782159 — DIAGNOSTIC KIT, FERRITAB-FE-59 (February 1, 1979)
  • K781769 — IRON 59 KIT (December 4, 1978)
  • K760045 — KIT, RADIOASSAY, SERUM IRON (July 20, 1976)

FDA data resources