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510(k) K792279

AUTOPAK 12 INSULIN TEST DELIVERY SYSTEM by Micromedic Systems — Product Code CFP

K792279 is an FDA 510(k) premarket notification submitted by Micromedic Systems for the device "AUTOPAK 12 INSULIN TEST DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on December 6, 1979. The device falls under product code CFP (Radioimmunoassay, Immunoreactive Insulin), a Class I device regulated under 21 CFR 862.1405. Micromedic Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1979
Date Received
November 13, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Immunoreactive Insulin
Device Class
Class I
Regulation Number
862.1405
Review Panel
CH
Submission Type

Other clearances by Micromedic Systems

  • K923643 — MEDICOOL (March 31, 1993)
  • K872309 — MICROMEDIC COMBOSTAT LH/FSH KIT (July 31, 1987)
  • K871008 — MICROMEDIC NEONATAL T4 KIT (May 26, 1987)
  • K870904 — MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT (May 26, 1987)
  • K871505 — AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT (May 26, 1987)
  • K870245 — AUTOPAK TSH MONOCLONAL IRMA KIT (April 1, 1987)
  • K862206 — TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER (August 4, 1986)
  • K860813 — MICROMEDIC HTSH MONOCLONAL IRMA KIT (July 14, 1986)
  • K861262 — MMS T3 UPTAKE (May 23, 1986)
  • K861320 — MMS T4 RIA KIT (April 24, 1986)

Other clearances for product code CFP

  • K963911 — ALPCO/MERCODIA INSULIN ELISA (November 1, 1996)
  • K953084 — ACCESS ULTRASENSITIVE INSULIN ASSAY (September 25, 1995)
  • K920109 — IMX INSULIN (May 7, 1992)
  • K914820 — DSL INSULIN RIA (DSL 1600) (January 9, 1992)
  • K903628 — AIA-PACK IRI (September 7, 1990)
  • K901135 — ENZYMUN TEST(R) INSULIN (April 3, 1990)
  • K896572 — REP(TM) SPE PLUS-30 PROCEDURES (January 11, 1990)
  • K890837 — RIA-GNOST INSULIN (April 26, 1989)
  • K851071 — PHARMACIA INSULIN RIA (April 12, 1985)
  • K841573 — INSULIN RADIOIMMUNOASSAY KIT (May 16, 1984)

FDA data resources