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FDA 510(k)

NATAL CALF (BOVINE) SERUM - STERILE

K-Number: K812385 · 1981-09-08

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

Device Summary

NATAL CALF (BOVINE) 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 K812385. 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 NATAL CALF (BOVINE) SERUM - STERILE?

NATAL CALF (BOVINE) 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 K812385.

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

NATAL CALF (BOVINE) SERUM - STERILE received FDA 510(k) clearance on 1981-09-08, under 510(k) number K812385.

Who is the listed applicant for NATAL CALF (BOVINE) 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 NATAL CALF (BOVINE) SERUM - STERILE?

The FDA product code for NATAL CALF (BOVINE) SERUM - STERILE is KIS.

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Other records listing Dutchland Laboratories, Inc. as applicant

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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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