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510(k) K854016

ASSERACHROM PROTEIN C KIT by American Bioproducts Co. — Product Code JLA

K854016 is an FDA 510(k) premarket notification submitted by American Bioproducts Co. for the device "ASSERACHROM PROTEIN C KIT". The FDA issued a decision of Substantially Equivalent on January 3, 1986. The device falls under product code JLA (Conversion To Creatinine, Creatine), a Class I device regulated under 21 CFR 862.1210. American Bioproducts Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1986
Date Received
September 27, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conversion To Creatinine, Creatine
Device Class
Class I
Regulation Number
862.1210
Review Panel
CH
Submission Type

Other clearances by American Bioproducts Co.

  • K983460 — STAR AUTOMATED MULTI-PARAMETRIC ANALYZER (November 12, 1998)
  • K971519 — ASSERACHROM TPA TEST KIT (August 19, 1997)
  • K964716 — STA LIATEST CONTROL [N]+[P] KIT (June 26, 1997)
  • K964728 — STA-LIATEST D-DI TEST KIT (June 26, 1997)
  • K964718 — STA D-DI CALIBRATOR KIT (May 23, 1997)
  • K962675 — STA - LIATEST VWF TEST KIT (October 25, 1996)
  • K962671 — STA-VWF CALIBRATOR KIT (September 13, 1996)
  • K962674 — STA - VWF CONTROL [N]+[P] KIT (July 23, 1996)
  • K961579 — STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER (July 10, 1996)
  • K955040 — AT-III CONTROL PLASMA KIT (January 31, 1996)

Other clearances for product code JLA

  • K852767 — ERYTHOCYTE CREATINE (November 13, 1986)

FDA data resources