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FDA 510(k)

B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN)

K-Number: K971935 · 1997-10-01

ApplicantB & D Corp.
Decision Date1997-10-01
Product CodeJBP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN) is the device name listed in this FDA 510(k) record. The listed applicant is B & D Corp.. It received FDA 510(k) clearance on 1997-10-01 under 510(k) number K971935. 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 B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN)?

B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN) is a medical device that received FDA 510(k) clearance on 1997-10-01. The listed applicant is B & D Corp.. The 510(k) number is K971935.

When did B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN) receive FDA 510(k) clearance?

B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN) received FDA 510(k) clearance on 1997-10-01, under 510(k) number K971935.

Who is the listed applicant for B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN)?

The FDA 510(k) record lists B & D Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN)?

The FDA product code for B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN) is JBP.

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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

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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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