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510(k) K760198

KIT, PLATELET AGGREGATION REAGENT (#390) by Chrono-Log Corp. — Product Code GHR

K760198 is an FDA 510(k) premarket notification submitted by Chrono-Log Corp. for the device "KIT, PLATELET AGGREGATION REAGENT (#390)". The FDA issued a decision of Substantially Equivalent on July 19, 1976. The device falls under product code GHR (Reagent, Platelet Aggregation), a Class II device regulated under 21 CFR 864.5700. Chrono-Log Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1976
Date Received
July 6, 1976
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

Other clearances by Chrono-Log Corp.

  • K161329 — Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 (December 2, 2016)
  • K050265 — CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 (October 14, 2005)
  • K032951 — CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A (April 2, 2004)
  • K962426 — CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592 (October 22, 1996)
  • K945414 — RISTOCETIN COFACTOR ASSAY KIT (January 11, 1995)
  • K940792 — AGGRO/LINK VW COFACTOR SOFTWARE (October 13, 1994)
  • K932566 — AGGRO/LINK CONTROL SOFTWARE (November 2, 1993)
  • K922800 — PLATELET AGGREGATION REAGENTS (August 26, 1992)
  • K851025 — AGGRO/LINK COMPUTER INTERFACE (June 12, 1985)
  • K850592 — PLATELET AGGREGATION REAGENT (May 13, 1985)

Other clearances for product code GHR

  • K061991 — PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA (February 23, 2007)
  • K952252 — ADP REAGENT, MODIFIED (September 8, 1995)
  • K922800 — PLATELET AGGREGATION REAGENTS (August 26, 1992)
  • K910706 — COLLAGEN REAGENT CAT. NO. 5368 (May 20, 1991)
  • K910680 — EPINEPHRINE REAGENT, CAT. NO. 5367 (May 20, 1991)
  • K910800 — ADP REAGENT (May 20, 1991)
  • K910286 — PLATELET AGGREGATION REAGENTS (March 19, 1991)
  • K900792 — RISTOCETIN (March 27, 1990)
  • K832428 — PLATELET AGGREGATION REAGENT SET (October 20, 1983)
  • K820422 — PLATELET AGGREGOMETERS (March 16, 1982)

FDA data resources