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FDA 510(k)

FETAL BOVINE SERUM

K-Number: K870938 · 1987-03-31

ApplicantHyclone Laboratories, Inc.
Decision Date1987-03-31
Product CodeKIS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FETAL BOVINE 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 1987-03-31 under 510(k) number K870938. 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 FETAL BOVINE SERUM?

FETAL BOVINE SERUM is a medical device that received FDA 510(k) clearance on 1987-03-31. The listed applicant is Hyclone Laboratories, Inc.. The 510(k) number is K870938.

When did FETAL BOVINE SERUM receive FDA 510(k) clearance?

FETAL BOVINE SERUM received FDA 510(k) clearance on 1987-03-31, under 510(k) number K870938.

Who is the listed applicant for FETAL BOVINE 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 FETAL BOVINE SERUM?

The FDA product code for FETAL BOVINE SERUM 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 SERUMK880471BOVINE CALF SERUM SUPPLEMENTED #A-2159K880470BOVINE CALF SERUM CATALOG #A-2119K870467DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151K870464CHARACTERIZED FETAL BOVINE SERUM #A-1115K870469DEFINED EQUINE SERUM #A-3311

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 LaboratoriesK880471BOVINE CALF SERUM SUPPLEMENTED #A-2159Hyclone Laboratories, Inc.K880470BOVINE CALF SERUM CATALOG #A-2119Hyclone Laboratories, Inc.K872847SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENTCandace Lane Corp.K870580MLC NORMAL SERUMRjo Biologicals, Inc.K870466DEFINED CALF BOVINE SERUM #A-2111Hyclone 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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