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FDA 510(k)

ALPHACALF SERUM

K-Number: K884654 · 1988-11-30

ApplicantHyclone Laboratories, Inc.
Decision Date1988-11-30
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ALPHACALF SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Hyclone Laboratories, Inc.. It received FDA 510(k) clearance on 1988-11-30 under 510(k) number K884654. 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 ALPHACALF SERUM?

ALPHACALF SERUM is a medical device that received FDA 510(k) clearance on 1988-11-30. The listed applicant is Hyclone Laboratories, Inc.. The 510(k) number is K884654.

When did ALPHACALF SERUM receive FDA 510(k) clearance?

ALPHACALF SERUM received FDA 510(k) clearance on 1988-11-30, under 510(k) number K884654.

Who is the listed applicant for ALPHACALF SERUM?

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

What is the FDA product code for ALPHACALF SERUM?

The FDA product code for ALPHACALF SERUM is KIT.

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Other records listing Hyclone Laboratories, 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.

K880471BOVINE CALF SERUM SUPPLEMENTED #A-2159K880470BOVINE CALF SERUM CATALOG #A-2119K870938FETAL BOVINE SERUMK870468ADULT BOVINE SERUMK870467DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151K870464CHARACTERIZED FETAL BOVINE SERUM #A-1115

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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.K884572RPMI-1640 HYBRI-MAX, PROD. NO. R5382Sigma Chemical Co.K884574DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785Sigma 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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