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510(k) K821151

RIA-QUANT FPA TEST KIT by Mallinckrodt Critical Care — Product Code DAN

K821151 is an FDA 510(k) premarket notification submitted by Mallinckrodt Critical Care for the device "RIA-QUANT FPA TEST KIT". The FDA issued a decision of Substantially Equivalent on July 22, 1982. The device falls under product code DAN (Fibrinopeptide A, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5350. Mallinckrodt Critical Care has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1982
Date Received
April 26, 1982
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 Mallinckrodt Critical Care

  • K880343 — BURNEY GALLBLADDER CATHETER KIT (May 1, 1989)
  • K874605 — HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR (February 2, 1988)
  • K874514 — HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE (January 29, 1988)
  • K874568 — HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR (January 6, 1988)
  • K874404 — HI-LO TEMP(R) SKIN TEMPERATURE SENSOR (November 6, 1987)
  • K873461 — LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) (November 6, 1987)
  • K873833 — THERMOCOUPLE ADAPTER (November 3, 1987)
  • K873004 — GUIDING CATHETER (September 15, 1987)
  • K871204 — CUFFED TRACHEAL TUBE (MULTIPLE) (April 21, 1987)
  • K862666 — UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) (August 1, 1986)

Other clearances for product code DAN

  • K884496 — RIA/MAT FPA TEST KIT (November 16, 1988)
  • K854384 — ASSERACHROM FPA KIT (February 4, 1986)

FDA data resources