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FDA 510(k)

BOVINE CALF SERUM CATALOG #A-2119

K-Number: K880470 · 1988-04-01

ApplicantHyclone Laboratories, Inc.
Decision Date1988-04-01
Product CodeKIS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BOVINE CALF SERUM CATALOG #A-2119 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 1988-04-01 under 510(k) number K880470. 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 CATALOG #A-2119?

BOVINE CALF SERUM CATALOG #A-2119 is a medical device that received FDA 510(k) clearance on 1988-04-01. The listed applicant is Hyclone Laboratories, Inc.. The 510(k) number is K880470.

When did BOVINE CALF SERUM CATALOG #A-2119 receive FDA 510(k) clearance?

BOVINE CALF SERUM CATALOG #A-2119 received FDA 510(k) clearance on 1988-04-01, under 510(k) number K880470.

Who is the listed applicant for BOVINE CALF SERUM CATALOG #A-2119?

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 CATALOG #A-2119?

The FDA product code for BOVINE CALF SERUM CATALOG #A-2119 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-2159K870938FETAL 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 LaboratoriesK880471BOVINE CALF SERUM SUPPLEMENTED #A-2159Hyclone 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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