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510(k) K880711

CLP 0.02 M CALCIUM CHLORIDE SOLUTION. by Creative Laboratory Products, Inc. — Product Code GIT

K880711 is an FDA 510(k) premarket notification submitted by Creative Laboratory Products, Inc. for the device "CLP 0.02 M CALCIUM CHLORIDE SOLUTION.". The FDA issued a decision of Substantially Equivalent on March 18, 1988. The device falls under product code GIT (Reagent & Control, Partial Thromboplastin Time), a Class II device regulated under 21 CFR 864.7925. Creative Laboratory Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1988
Date Received
February 22, 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 Creative Laboratory Products, Inc.

  • K950589 — CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HL (March 20, 1995)
  • K942284 — CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET (August 26, 1994)
  • K922995 — LIPID CONTROLS (August 12, 1992)
  • K913427 — SICKLE HEMOGLOBIN (HBA/S) CONTROL SET (November 19, 1991)
  • K913371 — TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL (November 8, 1991)
  • K913585 — LIPASE LINEARITY CONTROL (October 21, 1991)
  • K913224 — LIPID LINEARITY CONTROLS (September 25, 1991)
  • K913496 — CHOLINESTERASE LINEARITY CONTROL (September 11, 1991)
  • K912823 — HIGH DENSITY LIPOPROTEIN CHOLESTEROL (August 16, 1991)
  • K912725 — TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL (July 30, 1991)

Other clearances for product code GIT

  • K890051 — BIOTRACK APTT CONTROLS (February 23, 1989)
  • K881999 — PLATELIN(R) EXCEL L (August 17, 1988)
  • K820450 — THROMBOSCREEN (March 26, 1982)

FDA data resources