Product code CFP— Clinical Chemistry

FDA has cleared 27 devices under product code CFP between 1977 and 1996, filed by 24 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19961 clearance
• 19951 clearance
• 19922 clearances
• 19903 clearances
• 19891 clearance
• 19851 clearance
• 19841 clearance
• 19831 clearance
• 19823 clearances
• 19814 clearances
• 19793 clearances
• 19784 clearances
• 19772 clearances

• Ventrex Laboratories, Inc.2 clearances
• Micromedic Systems2 clearances
• Bd Becton Dickinson Vacutainer Systems Preanalytic2 clearances
• Wako Chemicals USA, Inc.1 clearance
• Union Carbide Corp.1 clearance
• Tosoh Corp.1 clearance
• Sorin Biomedica, Fiat, USA, Inc.1 clearance
• Serono Laboratories, Inc.1 clearance
• Radioassay Systems Laboratories, Inc.1 clearance
• Pharmacia, Inc.1 clearance

• K963911 — ALPCO/MERCODIA INSULIN ELISAAmerican Laboratory Products Co., Ltd.·1996-11-01
• K953084 — ACCESS ULTRASENSITIVE INSULIN ASSAYBio-Rad Laboratories, Inc.·1995-09-25
• K920109 — IMX INSULINAbbott Laboratories·1992-05-07
• K914820 — DSL INSULIN RIA (DSL 1600)Diagnostic Systems Laboratories, Inc.·1992-01-09
• K903628 — AIA-PACK IRITosoh Corp.·1990-09-07
• K901135 — ENZYMUN TEST(R) INSULINBoehringer Mannheim Corp.·1990-04-03
• K896572 — REP(TM) SPE PLUS-30 PROCEDURESHelena Laboratories·1990-01-11
• K890837 — RIA-GNOST INSULINCambridge Medical Technology·1989-04-26
• K851071 — PHARMACIA INSULIN RIAPharmacia, Inc.·1985-04-12
• K841573 — INSULIN RADIOIMMUNOASSAY KITSorin Biomedica, Fiat, USA, Inc.·1984-05-16
• K823939 — WAKO INSULIN TESTWako Chemicals USA, Inc.·1983-01-28
• K822509 — COVALENT COAT RIA KITImmuchem Corp.·1982-09-28
• K821861 — COAT-A-COUNT INSULIN KITDiagnostic Products Corp.·1982-07-08
• K821374 — ENZYMUNE-TEST INSULINIcl Scientific·1982-05-28
• K812227 — GAMMACOAT (125) INSULIN RADIOIMMUNOASSAYClinical Assays, Inc.·1981-09-24
• K811953 — IMMOPHASE INSULIN (125I) RADIOASSAYCorning Medical & Scientific·1981-07-23
• K811423 — VENTRE/SEPVentrex Laboratories, Inc.·1981-06-09
• K811144 — ARIA II INSULIN RIABd Becton Dickinson Vacutainer Systems Preanalytic·1981-05-15
• K792279 — AUTOPAK 12 INSULIN TEST DELIVERY SYSTEMMicromedic Systems·1979-12-06
• K791707 — CENTRIA INSULIN RIAVentrex Laboratories, Inc.·1979-10-17
• K790630 — RIA, INSULIN, DOUBLE ANTIBODYEndocrine-Metabolic Center·1979-07-24
• K781086 — INSULIN AUTOPAKMicromedic Systems·1978-08-14
• K781285 — INSULIN RIA KITSerono Laboratories, Inc.·1978-08-14
• K771947 — INSULIN RIA MODULEInter Science Institute·1978-01-20
• K772281 — RSL INSULIN KITRadioassay Systems Laboratories, Inc.·1978-01-06
• K771979 — CENTRIA INSULIN RIAUnion Carbide Corp.·1977-11-17
• K771628 — NSULIN RIA KIT 125IBd Becton Dickinson Vacutainer Systems Preanalytic·1977-09-20