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FDA 510(k)

SIMUL-FER SERUM IRON TEST KIT

K-Number: K820253 · 1982-05-12

ApplicantDiagnostic Reagents, Inc.
Decision Date1982-05-12
Product CodeJJA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SIMUL-FER SERUM IRON TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Reagents, Inc.. It received FDA 510(k) clearance on 1982-05-12 under 510(k) number K820253. The device is classified under product code JJA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMUL-FER SERUM IRON TEST KIT?

SIMUL-FER SERUM IRON TEST KIT is a medical device that received FDA 510(k) clearance on 1982-05-12. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K820253.

When did SIMUL-FER SERUM IRON TEST KIT receive FDA 510(k) clearance?

SIMUL-FER SERUM IRON TEST KIT received FDA 510(k) clearance on 1982-05-12, under 510(k) number K820253.

Who is the listed applicant for SIMUL-FER SERUM IRON TEST KIT?

The FDA 510(k) record lists Diagnostic Reagents, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIMUL-FER SERUM IRON TEST KIT?

The FDA product code for SIMUL-FER SERUM IRON TEST KIT is JJA.

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Other records listing Diagnostic Reagents, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K983268MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAYK983812NAPA EIA ASSAYK983323DIGOXIN IMMUNOASSAYK983280VANCOMYCIN EIA ASSAYK983159DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLSK973102LIDOCAINE EIA ASSAY

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Related Devices (Code: JJA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K782159DIAGNOSTIC KIT, FERRITAB-FE-59Leeco Diagnostics, Inc.K781769IRON 59 KITRia Products, Inc.K760045KIT, RADIOASSAY, SERUM IRONBd Becton Dickinson Vacutainer Systems Preanalytic

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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