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510(k) K971935

B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN) by B & D Corp. — Product Code JBP

K971935 is an FDA 510(k) premarket notification submitted by B & D Corp. for the device "B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN)". The FDA issued a decision of Substantially Equivalent on October 1, 1997. The device falls under product code JBP (Activated Whole Blood Clotting Time), a Class II device regulated under 21 CFR 864.7140.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1997
Date Received
May 27, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activated Whole Blood Clotting Time
Device Class
Class II
Regulation Number
864.7140
Review Panel
HE
Submission Type

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  • K023582 — I-STAT KAOLIN ACT TEST (September 8, 2003)
  • K020914 — ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 (May 23, 2002)
  • K013078 — ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 (January 10, 2002)
  • K002528 — SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER O (August 31, 2000)
  • K994194 — (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT (March 28, 2000)
  • K992571 — I-STAT SYSTEM (February 10, 2000)
  • K992851 — ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYST (January 14, 2000)

FDA data resources