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FDA 510(k)

NEWBORN CALF SERUM - STERILE

K-Number: K812384 · 1981-09-08

ApplicantDutchland Laboratories, Inc.
Decision Date1981-09-08
Product CodeKIS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

NEWBORN CALF SERUM - STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Dutchland Laboratories, Inc.. It received FDA 510(k) clearance on 1981-09-08 under 510(k) number K812384. 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 NEWBORN CALF SERUM - STERILE?

NEWBORN CALF SERUM - STERILE is a medical device that received FDA 510(k) clearance on 1981-09-08. The listed applicant is Dutchland Laboratories, Inc.. The 510(k) number is K812384.

When did NEWBORN CALF SERUM - STERILE receive FDA 510(k) clearance?

NEWBORN CALF SERUM - STERILE received FDA 510(k) clearance on 1981-09-08, under 510(k) number K812384.

Who is the listed applicant for NEWBORN CALF SERUM - STERILE?

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

What is the FDA product code for NEWBORN CALF SERUM - STERILE?

The FDA product code for NEWBORN CALF SERUM - STERILE is KIS.

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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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