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510(k) K854015

FS TEST KIT by American Bioproducts Co. — Product Code JBN

K854015 is an FDA 510(k) premarket notification submitted by American Bioproducts Co. for the device "FS TEST KIT". The FDA issued a decision of Substantially Equivalent on March 6, 1986. The device falls under product code JBN (Fibrin Monomer Paracoagulation), a Class II device regulated under 21 CFR 864.7300. American Bioproducts Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1986
Date Received
September 27, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fibrin Monomer Paracoagulation
Device Class
Class II
Regulation Number
864.7300
Review Panel
HE
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)
  • K964728 — STA-LIATEST D-DI TEST KIT (June 26, 1997)
  • K964716 — STA LIATEST CONTROL [N]+[P] 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 JBN

  • K781814 — SULFATE, FIBRIQUIK PROTAMINE (November 8, 1978)

FDA data resources