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510(k) K790986

RF CONTROLS by Wampole Laboratories — Product Code DMR

K790986 is an FDA 510(k) premarket notification submitted by Wampole Laboratories for the device "RF CONTROLS". The FDA issued a decision of Substantially Equivalent on June 28, 1979. The device falls under product code DMR (Solution, M-Nitrophenol, Specific Reagent For Cholinesterase), a Class I device regulated under 21 CFR 862.3240. Wampole Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1979
Date Received
May 25, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solution, M-Nitrophenol, Specific Reagent For Cholinesterase
Device Class
Class I
Regulation Number
862.3240
Review Panel
TX
Submission Type

Other clearances by Wampole Laboratories

  • K965129 — BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM (March 26, 1997)
  • K965131 — BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM (March 26, 1997)
  • K911444 — RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM (August 30, 1991)
  • K882896 — ONE-STEP HCG (October 31, 1988)
  • K883004 — MONO-PLUS(TM) (August 4, 1988)
  • K875101 — VIROGEN CMV ANTIBODY TEST (March 1, 1988)
  • K875161 — MAT (TM) MICROALBUMIN TEST (February 17, 1988)
  • K791309 — UCG-LYPHOTEST (July 30, 1979)
  • K781794 — BETA-TEC (December 29, 1978)
  • K760336 — BIOCEPT-G (November 12, 1976)

FDA data resources