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510(k) K881999

PLATELIN(R) EXCEL L by Organon Teknika Corp. — Product Code GIT

K881999 is an FDA 510(k) premarket notification submitted by Organon Teknika Corp. for the device "PLATELIN(R) EXCEL L". The FDA issued a decision of Substantially Equivalent on August 17, 1988. The device falls under product code GIT (Reagent & Control, Partial Thromboplastin Time), a Class II device regulated under 21 CFR 864.7925. Organon Teknika Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1988
Date Received
May 12, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent & Control, Partial Thromboplastin Time
Device Class
Class II
Regulation Number
864.7925
Review Panel
HE
Submission Type

Other clearances by Organon Teknika Corp.

  • K003104 — BACT/ALERT CSR (October 20, 2000)
  • K000492 — MDA D-DIMER (June 7, 2000)
  • K000378 — BACT/ALERT MB CULTURE BOTTLE (March 2, 2000)
  • K994343 — BACT/ALERT SV (February 10, 2000)
  • K993423 — BACT/ALERT SA (December 15, 1999)
  • K993421 — BACT/ALERT SN (December 14, 1999)
  • K993576 — BACT/ALERT MP PROCESS BOTTLE (December 14, 1999)
  • K992432 — BACT/ALERT FN (September 24, 1999)
  • K983762 — NUCLISENS CMV PP67 (September 15, 1999)
  • K992401 — BACT/ALERT PF (September 3, 1999)

Other clearances for product code GIT

  • K890051 — BIOTRACK APTT CONTROLS (February 23, 1989)
  • K880711 — CLP 0.02 M CALCIUM CHLORIDE SOLUTION. (March 18, 1988)
  • K820450 — THROMBOSCREEN (March 26, 1982)

FDA data resources