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FDA 510(k)

BOVINE CALF SERUM SUPPLEMENTED #A-2159

K-Number: K880471 · 1988-04-04

ApplicantHyclone Laboratories, Inc.
Decision Date1988-04-04
Product CodeKIS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BOVINE CALF SERUM SUPPLEMENTED #A-2159 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 1988-04-04 under 510(k) number K880471. The device is classified under product code KIS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOVINE CALF SERUM SUPPLEMENTED #A-2159?

BOVINE CALF SERUM SUPPLEMENTED #A-2159 is a medical device that received FDA 510(k) clearance on 1988-04-04. The listed applicant is Hyclone Laboratories, Inc.. The 510(k) number is K880471.

When did BOVINE CALF SERUM SUPPLEMENTED #A-2159 receive FDA 510(k) clearance?

BOVINE CALF SERUM SUPPLEMENTED #A-2159 received FDA 510(k) clearance on 1988-04-04, under 510(k) number K880471.

Who is the listed applicant for BOVINE CALF SERUM SUPPLEMENTED #A-2159?

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 BOVINE CALF SERUM SUPPLEMENTED #A-2159?

The FDA product code for BOVINE CALF SERUM SUPPLEMENTED #A-2159 is KIS.

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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.

K884654ALPHACALF SERUMK880470BOVINE CALF SERUM CATALOG #A-2119K870938FETAL BOVINE SERUMK870468ADULT BOVINE SERUMK870467DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151K870464CHARACTERIZED FETAL BOVINE SERUM #A-1115

View all 11 devices →

Related Devices (Code: KIS)

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.

K881287ANIMAL AND HUMAN SERACell Culture LaboratoriesK880470BOVINE CALF SERUM CATALOG #A-2119Hyclone Laboratories, Inc.K872847SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENTCandace Lane Corp.K870580MLC NORMAL SERUMRjo Biologicals, Inc.K870938FETAL BOVINE SERUMHyclone Laboratories, Inc.K870469DEFINED EQUINE SERUM #A-3311Hyclone Laboratories, Inc.

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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