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FDA 510(k)

BIO-CARB D16000, D16001, AND D17000

K-Number: K861646 · 1986-08-07

ApplicantSociete D' Analyses Bio-Pharmaceutiques,Inc.
Decision Date1986-08-07
Product CodeFJH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIO-CARB D16000, D16001, AND D17000 is the device name listed in this FDA 510(k) record. The listed applicant is Societe D' Analyses Bio-Pharmaceutiques,Inc.. It received FDA 510(k) clearance on 1986-08-07 under 510(k) number K861646. The device is classified under product code FJH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-CARB D16000, D16001, AND D17000?

BIO-CARB D16000, D16001, AND D17000 is a medical device that received FDA 510(k) clearance on 1986-08-07. The listed applicant is Societe D' Analyses Bio-Pharmaceutiques,Inc.. The 510(k) number is K861646.

When did BIO-CARB D16000, D16001, AND D17000 receive FDA 510(k) clearance?

BIO-CARB D16000, D16001, AND D17000 received FDA 510(k) clearance on 1986-08-07, under 510(k) number K861646.

Who is the listed applicant for BIO-CARB D16000, D16001, AND D17000?

The FDA 510(k) record lists Societe D' Analyses Bio-Pharmaceutiques,Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-CARB D16000, D16001, AND D17000?

The FDA product code for BIO-CARB D16000, D16001, AND D17000 is FJH.

Related Devices (Code: FJH)

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.

K920697DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMPNational Medical Care, Medical Products Div., Inc.K852764IDECAP DIALYZERTrans-National Trade Development Corp.K822395CF 1211 CAPILLARY FLOW DIALYZER CODETravenol Laboratories, S.A.

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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