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510(k) K854384

ASSERACHROM FPA KIT by American Bioproducts Co. — Product Code DAN

K854384 is an FDA 510(k) premarket notification submitted by American Bioproducts Co. for the device "ASSERACHROM FPA KIT". The FDA issued a decision of Substantially Equivalent on February 4, 1986. The device falls under product code DAN (Fibrinopeptide A, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5350. American Bioproducts Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1986
Date Received
October 30, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fibrinopeptide A, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5350
Review Panel
IM
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 DAN

  • K884496 — RIA/MAT FPA TEST KIT (November 16, 1988)
  • K821151 — RIA-QUANT FPA TEST KIT (July 22, 1982)

FDA data resources