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FDA 510(k)

CHANG MEDIUM (ADDITIONAL INDICATIONS)

K-Number: K883682 · 1988-09-16

ApplicantHana Biologics, Inc.
Decision Date1988-09-16
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CHANG MEDIUM (ADDITIONAL INDICATIONS) 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 1988-09-16 under 510(k) number K883682. 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 (ADDITIONAL INDICATIONS)?

CHANG MEDIUM (ADDITIONAL INDICATIONS) is a medical device that received FDA 510(k) clearance on 1988-09-16. The listed applicant is Hana Biologics, Inc.. The 510(k) number is K883682.

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

CHANG MEDIUM (ADDITIONAL INDICATIONS) received FDA 510(k) clearance on 1988-09-16, under 510(k) number K883682.

Who is the listed applicant for CHANG MEDIUM (ADDITIONAL INDICATIONS)?

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 (ADDITIONAL INDICATIONS)?

The FDA product code for CHANG MEDIUM (ADDITIONAL INDICATIONS) is KIT.

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Other records listing Hana Biologics, Inc. as applicant

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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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