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FDA 510(k)

FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB

K-Number: K853803 · 1985-10-15

ApplicantZ.L. Bocknek Laboratories, Inc.
Decision Date1985-10-15
Product CodeKIS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB is the device name listed in this FDA 510(k) record. The listed applicant is Z.L. Bocknek Laboratories, Inc.. It received FDA 510(k) clearance on 1985-10-15 under 510(k) number K853803. 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/FETAL CALF SERUM, NEWBORN, HORSE, RAB?

FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB is a medical device that received FDA 510(k) clearance on 1985-10-15. The listed applicant is Z.L. Bocknek Laboratories, Inc.. The 510(k) number is K853803.

When did FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB receive FDA 510(k) clearance?

FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB received FDA 510(k) clearance on 1985-10-15, under 510(k) number K853803.

Who is the listed applicant for FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB?

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

What is the FDA product code for FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB?

The FDA product code for FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB is KIS.

Related Clinical Trials

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.

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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.K870938FETAL BOVINE SERUMHyclone Laboratories, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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