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FDA 510(k)

DECARBOXYLASE TEST REAGENT

K-Number: K842869 · 1984-08-07

ApplicantIrvine Diagnostic Services
Decision Date1984-08-07
Product CodeJSF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DECARBOXYLASE TEST REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Irvine Diagnostic Services. It received FDA 510(k) clearance on 1984-08-07 under 510(k) number K842869. The device is classified under product code JSF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DECARBOXYLASE TEST REAGENT?

DECARBOXYLASE TEST REAGENT is a medical device that received FDA 510(k) clearance on 1984-08-07. The listed applicant is Irvine Diagnostic Services. The 510(k) number is K842869.

When did DECARBOXYLASE TEST REAGENT receive FDA 510(k) clearance?

DECARBOXYLASE TEST REAGENT received FDA 510(k) clearance on 1984-08-07, under 510(k) number K842869.

Who is the listed applicant for DECARBOXYLASE TEST REAGENT?

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

What is the FDA product code for DECARBOXYLASE TEST REAGENT?

The FDA product code for DECARBOXYLASE TEST REAGENT is JSF.

Related Clinical Trials

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.

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Other records listing Irvine Diagnostic Services 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.

K842871HIPPURATE TEST REAGENTK842868HIPPURATE TEST DISKSK842870VOGES-PROSKAUER REAGENT AK842867VOGES-PROSKAUER REAGENT BK842872INDOLE REAGENTK842299ZINC DUST SUSPENSION

View all 10 devices →

Related Devices (Code: JSF)

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.

K880946NUTRIENT GELATIN - PRODUCT NUMBER T2860Lakewood Biochemical Co., Inc.K880126LAURYL TRYPTOSE BROTHHardy MediaK880119MOELLERS DECARBOXYLASE, ONITHINEHardy MediaK880120MOELLERS DECARBOXYLASE, LYSINEHardy MediaK880139ONPG TEST REAGENTHardy MediaK880113CYSTINE TRYPTIC MEDIUM W/LACTOSEHardy Media

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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