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FDA 510(k)

GBACT + KIT

K-Number: K984141 · 1999-05-28

ApplicantSienco, Inc.
Decision Date1999-05-28
Product CodeJBP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GBACT + KIT is the device name listed in this FDA 510(k) record. The listed applicant is Sienco, Inc.. It received FDA 510(k) clearance on 1999-05-28 under 510(k) number K984141. The device is classified under product code JBP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GBACT + KIT?

GBACT + KIT is a medical device that received FDA 510(k) clearance on 1999-05-28. The listed applicant is Sienco, Inc.. The 510(k) number is K984141.

When did GBACT + KIT receive FDA 510(k) clearance?

GBACT + KIT received FDA 510(k) clearance on 1999-05-28, under 510(k) number K984141.

Who is the listed applicant for GBACT + KIT?

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

What is the FDA product code for GBACT + KIT?

The FDA product code for GBACT + KIT is JBP.

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Other records listing Sienco, Inc. as applicant

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.

K223635Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot ViewerK032952AIACT KITK002528SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTIONK952560SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER

Related Devices (Code: JBP)

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.

K223635Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot ViewerSienco, Inc.K062604RAPIDTEG TEG-ACT TESTHaemoscope Corp.K032952AIACT KITSienco, Inc.K023582I-STAT KAOLIN ACT TESTI-Stat CorporationK020914ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770Helena LaboratoriesK013078ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752Helena Laboratories

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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