Home / 510(k) Clearances / K992851

510(k) K992851

ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM by Roche Diagnostics Corp. — Product Code JBP

K992851 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM". The FDA issued a decision of Substantially Equivalent on January 14, 2000. The device falls under product code JBP (Activated Whole Blood Clotting Time), a Class II device regulated under 21 CFR 864.7140. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2000
Date Received
August 24, 1999
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

Other clearances by Roche Diagnostics Corp.

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  • K252431 — Elecsys Calcitonin (April 24, 2026)
  • K252280 — Elecsys Anti-SARS-CoV-2 S (April 13, 2026)
  • K260048 — Elecsys Anti-HAV IgM (April 7, 2026)
  • K260046 — Elecsys Anti-HBc II (April 7, 2026)
  • K260049 — Elecsys Anti-HBc IgM (April 7, 2026)
  • K260026 — Tina-quant Cardiac high sensitivity CRP III (April 2, 2026)
  • K253491 — ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; (February 12, 2026)
  • K253490 — Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions (February 12, 2026)
  • K253839 — Elecsys Anti-SARS-CoV-2 (December 17, 2025)

Other clearances for product code JBP

  • K223635 — Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (January 4, 2023)
  • K062604 — RAPIDTEG TEG-ACT TEST (January 31, 2007)
  • K032952 — AIACT KIT (December 12, 2003)
  • 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)
  • K984141 — GBACT + KIT (May 28, 1999)

FDA data resources