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FDA 510(k)

PBS W/MG+2 & CA+2

K-Number: K834136 · 1984-03-22

ApplicantBartels Immunodiagnostic Supplies, Inc.
Decision Date1984-03-22
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PBS W/MG+2 & CA+2 is the device name listed in this FDA 510(k) record. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. It received FDA 510(k) clearance on 1984-03-22 under 510(k) number K834136. The device is classified under product code KIT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PBS W/MG+2 & CA+2?

PBS W/MG+2 & CA+2 is a medical device that received FDA 510(k) clearance on 1984-03-22. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. The 510(k) number is K834136.

When did PBS W/MG+2 & CA+2 receive FDA 510(k) clearance?

PBS W/MG+2 & CA+2 received FDA 510(k) clearance on 1984-03-22, under 510(k) number K834136.

Who is the listed applicant for PBS W/MG+2 & CA+2?

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

What is the FDA product code for PBS W/MG+2 & CA+2?

The FDA product code for PBS W/MG+2 & CA+2 is KIT.

Other records listing Bartels Immunodiagnostic Supplies, Inc. as applicant

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Related Devices (Code: KIT)

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.

K892938AMNIO-GROW TMInovar Biologicals, Inc.K890700MELANOCYTE GROWTH MEDIUM (MGM)Clonetics Corp.K890701ENDOTHELIAL GROWTH MEDIUM (EGM)Clonetics Corp.K890482ABC, ABC-1X, ABC(TM)Cell Ent., Inc.K884654ALPHACALF SERUMHyclone Laboratories, Inc.K884572RPMI-1640 HYBRI-MAX, PROD. NO. R5382Sigma Chemical Co.

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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