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FDA 510(k)

CELLGRO(ISCOVE'S MEDIUM) MODIFICATION

K-Number: K852485 · 1985-07-12

ApplicantMediatech, Inc.
Decision Date1985-07-12
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELLGRO(ISCOVE'S MEDIUM) MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Mediatech, Inc.. It received FDA 510(k) clearance on 1985-07-12 under 510(k) number K852485. 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 CELLGRO(ISCOVE'S MEDIUM) MODIFICATION?

CELLGRO(ISCOVE'S MEDIUM) MODIFICATION is a medical device that received FDA 510(k) clearance on 1985-07-12. The listed applicant is Mediatech, Inc.. The 510(k) number is K852485.

When did CELLGRO(ISCOVE'S MEDIUM) MODIFICATION receive FDA 510(k) clearance?

CELLGRO(ISCOVE'S MEDIUM) MODIFICATION received FDA 510(k) clearance on 1985-07-12, under 510(k) number K852485.

Who is the listed applicant for CELLGRO(ISCOVE'S MEDIUM) MODIFICATION?

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

What is the FDA product code for CELLGRO(ISCOVE'S MEDIUM) MODIFICATION?

The FDA product code for CELLGRO(ISCOVE'S MEDIUM) MODIFICATION is KIT.

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Other records listing Mediatech, 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.

K860623CELLGRO HEPES BUFFER SOLUTIONK854567PENICILLIN/STREPTOMYCIN SOLUTIONK852603MCCOY'S 5A MEDIUM - POWDERED FORMK852602MCCOY'S 5A MEDIUM-LIQUID FORMK852475CELLGRO WILLIAMS' MEDIUM EK852288CELLGRO

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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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