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FDA 510(k)

CHANG MEDIUM

K-Number: K812820 · 1981-11-10

ApplicantHana Biologics, Inc.
Decision Date1981-11-10
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CHANG MEDIUM is the device name listed in this FDA 510(k) record. The listed applicant is Hana Biologics, Inc.. It received FDA 510(k) clearance on 1981-11-10 under 510(k) number K812820. 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 CHANG MEDIUM?

CHANG MEDIUM is a medical device that received FDA 510(k) clearance on 1981-11-10. The listed applicant is Hana Biologics, Inc.. The 510(k) number is K812820.

When did CHANG MEDIUM receive FDA 510(k) clearance?

CHANG MEDIUM received FDA 510(k) clearance on 1981-11-10, under 510(k) number K812820.

Who is the listed applicant for CHANG MEDIUM?

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

What is the FDA product code for CHANG MEDIUM?

The FDA product code for CHANG MEDIUM is KIT.

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Other records listing Hana Biologics, 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.

K883682CHANG MEDIUM (ADDITIONAL INDICATIONS)K855205MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEMK834616AMNIO STAT-FLM AGGLUTINATION TESTK833933ACE COLOR TESTK822737MYCOTRIUM-RSK822736MYCOTRIUM-GU

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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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