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FDA 510(k)

OXIDASE TEST STRIPS-OXIDASESURE

K-Number: K842298 · 1984-06-25

ApplicantIrvine Diagnostic Services
Decision Date1984-06-25
Product CodeJSF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OXIDASE TEST STRIPS-OXIDASESURE 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 1984-06-25 under 510(k) number K842298. 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 OXIDASE TEST STRIPS-OXIDASESURE?

OXIDASE TEST STRIPS-OXIDASESURE is a medical device that received FDA 510(k) clearance on 1984-06-25. The listed applicant is Irvine Diagnostic Services. The 510(k) number is K842298.

When did OXIDASE TEST STRIPS-OXIDASESURE receive FDA 510(k) clearance?

OXIDASE TEST STRIPS-OXIDASESURE received FDA 510(k) clearance on 1984-06-25, under 510(k) number K842298.

Who is the listed applicant for OXIDASE TEST STRIPS-OXIDASESURE?

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 OXIDASE TEST STRIPS-OXIDASESURE?

The FDA product code for OXIDASE TEST STRIPS-OXIDASESURE is JSF.

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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.

K842869DECARBOXYLASE TEST REAGENTK842871HIPPURATE TEST REAGENTK842868HIPPURATE TEST DISKSK842870VOGES-PROSKAUER REAGENT AK842867VOGES-PROSKAUER REAGENT BK842872INDOLE REAGENT

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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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