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FDA 510(k)

CELL CULTURE REAGENTS

K-Number: K812531 · 1981-10-23

ApplicantM.A. Bioproducts
Decision Date1981-10-23
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELL CULTURE REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is M.A. Bioproducts. It received FDA 510(k) clearance on 1981-10-23 under 510(k) number K812531. The device is classified under product code KIT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELL CULTURE REAGENTS?

CELL CULTURE REAGENTS is a medical device that received FDA 510(k) clearance on 1981-10-23. The listed applicant is M.A. Bioproducts. The 510(k) number is K812531.

When did CELL CULTURE REAGENTS receive FDA 510(k) clearance?

CELL CULTURE REAGENTS received FDA 510(k) clearance on 1981-10-23, under 510(k) number K812531.

Who is the listed applicant for CELL CULTURE REAGENTS?

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

What is the FDA product code for CELL CULTURE REAGENTS?

The FDA product code for CELL CULTURE REAGENTS is KIT.

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Other records listing M.A. Bioproducts 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.

K822883HERPELISA KITK823804MYCOPLASMELISA TEST KITK830045MUMPSELISA TEST KITK830615CYTOMEGELISA STATK823805VARICELISA TEST KITK821967CHLAMYDELISA TEST KIT

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Related Devices (Code: KIT)

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.

K892938AMNIO-GROW TMInovar Biologicals, Inc.K890700MELANOCYTE GROWTH MEDIUM (MGM)Clonetics Corp.K890701ENDOTHELIAL GROWTH MEDIUM (EGM)Clonetics Corp.K890482ABC, ABC-1X, ABC(TM)Cell Ent., Inc.K884654ALPHACALF SERUMHyclone Laboratories, Inc.K884572RPMI-1640 HYBRI-MAX, PROD. NO. R5382Sigma Chemical Co.

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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