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FDA 510(k)

ONPG TEST REAGENT

K-Number: K880139 · 1988-03-30

ApplicantHardy Media
Decision Date1988-03-30
Product CodeJSF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ONPG TEST REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Media. It received FDA 510(k) clearance on 1988-03-30 under 510(k) number K880139. 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 ONPG TEST REAGENT?

ONPG TEST REAGENT is a medical device that received FDA 510(k) clearance on 1988-03-30. The listed applicant is Hardy Media. The 510(k) number is K880139.

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

ONPG TEST REAGENT received FDA 510(k) clearance on 1988-03-30, under 510(k) number K880139.

Who is the listed applicant for ONPG TEST REAGENT?

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

What is the FDA product code for ONPG TEST REAGENT?

The FDA product code for ONPG TEST REAGENT is JSF.

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Other records listing Hardy Media 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.

K880134MIDDLEBROOK 7H11 AGARK880122MIDDLEBROOK 7H9 BROTHK880131LOWENSTEIN-JENSEN, GRUFTK880133MIL MEDIUMK880126LAURYL TRYPTOSE BROTHK880116MRVP BROTH

View all 114 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 MediaK880113CYSTINE TRYPTIC MEDIUM W/LACTOSEHardy MediaK880135NITRATE BROTHHardy 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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