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510(k) K900792

RISTOCETIN by Medical Diagnostic Technologies, Inc. — Product Code GHR

K900792 is an FDA 510(k) premarket notification submitted by Medical Diagnostic Technologies, Inc. for the device "RISTOCETIN". The FDA issued a decision of Substantially Equivalent on Mar 27, 1990. The device falls under product code GHR (Reagent, Platelet Aggregation), a Class II device regulated under 21 CFR 864.5700. Medical Diagnostic Technologies, Inc. has 56 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 27, 1990
Date Received
Feb 20, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Reagent, Platelet Aggregation
Device Class
Class II
Regulation Number
864.5700
Review Panel
HE
Submission Type
510(k)

Other clearances by Medical Diagnostic Technologies, Inc.

  • K062229 — CTC WORKSTATION, MODEL 2200 (Sep 11, 2006)
  • K972209 — SPECTROLYSE HEPARIN (ANTI-IIA) (Aug 12, 1997)
  • K963106 — CHROMOLIZE PAI-1 KIT (Nov 18, 1996)
  • K960871 — SPECTROLYSE ANTITHROMBIN III (ANTI-XA) (Aug 14, 1996)
  • K962489 — CHROMOLIZE TPA ASSAY KIT (Jul 31, 1996)
  • K960438 — TINTELIZE PAI-1 KIT (Jun 5, 1996)
  • K961724 — U-DOA CONTROLS (Jun 3, 1996)
  • K961370 — LA POSITIVE CONTROL PLASMA (May 24, 1996)
  • K955115 — VENOM TIEM REAGENT (Apr 3, 1996)
  • K955738 — BIOCLOT PROTEIN S (Feb 29, 1996)

Other clearances for product code GHR

  • K061991 — PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA (Feb 23, 2007)
  • K952252 — ADP REAGENT, MODIFIED (Sep 8, 1995)
  • K922800 — PLATELET AGGREGATION REAGENTS (Aug 26, 1992)
  • K910680 — EPINEPHRINE REAGENT, CAT. NO. 5367 (May 20, 1991)
  • K910706 — COLLAGEN REAGENT CAT. NO. 5368 (May 20, 1991)
  • K910800 — ADP REAGENT (May 20, 1991)
  • K910286 — PLATELET AGGREGATION REAGENTS (Mar 19, 1991)
  • K832428 — PLATELET AGGREGATION REAGENT SET (Oct 20, 1983)
  • K820422 — PLATELET AGGREGOMETERS (Mar 16, 1982)
  • K760198 — KIT, PLATELET AGGREGATION REAGENT (#390) (Jul 19, 1976)

FDA data resources

Source: FDA 510(k) database entry for K900792. Report a data issue: hello@regdatalab.com.