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FDA 510(k)

GUINEA PIG WHOLE SERUM

K-Number: K780009 · 1978-01-20

ApplicantNortheast Biomedical Labs., Inc.
Decision Date1978-01-20
Product CodeKIS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GUINEA PIG WHOLE SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Northeast Biomedical Labs., Inc.. It received FDA 510(k) clearance on 1978-01-20 under 510(k) number K780009. 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 GUINEA PIG WHOLE SERUM?

GUINEA PIG WHOLE SERUM is a medical device that received FDA 510(k) clearance on 1978-01-20. The listed applicant is Northeast Biomedical Labs., Inc.. The 510(k) number is K780009.

When did GUINEA PIG WHOLE SERUM receive FDA 510(k) clearance?

GUINEA PIG WHOLE SERUM received FDA 510(k) clearance on 1978-01-20, under 510(k) number K780009.

Who is the listed applicant for GUINEA PIG WHOLE SERUM?

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

What is the FDA product code for GUINEA PIG WHOLE SERUM?

The FDA product code for GUINEA PIG WHOLE SERUM is KIS.

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Other records listing Northeast Biomedical Labs., 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.

K780697GOAT ANTI-INFLUENZA ANTISERA ATEXASK780696GOAT ANTIINFLUENZA ANTISERA AUSSRK780008GOAT ANTI-INFLUENZA ANTISERAK780004GOAT ANTI-INFLUENZA ANTISERAK780007GOAT ANTI-INFLUENZA ANTISERAK780006GOAT ANTI-INFLUENZA ANTISERA

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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

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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