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FDA 510(k)

MLC NORMAL SERUM

K-Number: K870580 · 1987-04-08

ApplicantRjo Biologicals, Inc.
Decision Date1987-04-08
Product CodeKIS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MLC NORMAL SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Rjo Biologicals, Inc.. It received FDA 510(k) clearance on 1987-04-08 under 510(k) number K870580. 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 MLC NORMAL SERUM?

MLC NORMAL SERUM is a medical device that received FDA 510(k) clearance on 1987-04-08. The listed applicant is Rjo Biologicals, Inc.. The 510(k) number is K870580.

When did MLC NORMAL SERUM receive FDA 510(k) clearance?

MLC NORMAL SERUM received FDA 510(k) clearance on 1987-04-08, under 510(k) number K870580.

Who is the listed applicant for MLC NORMAL SERUM?

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

What is the FDA product code for MLC NORMAL SERUM?

The FDA product code for MLC NORMAL SERUM 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.K870938FETAL BOVINE SERUMHyclone Laboratories, Inc.K870466DEFINED CALF BOVINE SERUM #A-2111Hyclone 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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