Product code CKG— Clinical Chemistry

FDA has cleared 30 devices under product code CKG between 1981 and 2023, filed by 22 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20231 clearance
• 20111 clearance
• 20061 clearance
• 20051 clearance
• 20021 clearance
• 20011 clearance
• 19981 clearance
• 19963 clearances
• 19941 clearance
• 19931 clearance
• 19921 clearance
• 19911 clearance
• 19901 clearance
• 19881 clearance
• 19861 clearance

• Nichols Institute Diagnostics3 clearances
• Diagnostic Systems Laboratories, Inc.3 clearances
• Syncor Intl. Corp.2 clearances
• Scantibodies Laboratory, Inc.2 clearances
• Immuno Nuclear Corp.2 clearances
• Diagnostic Products Corp.2 clearances
• Tosoh Bioscience, Inc.1 clearance
• Seragen Diagnostics, Inc.1 clearance
• Science Regulatory Services Intl.1 clearance
• Sangui Biotech, Inc.1 clearance

• K223867 — IDS ACTH IIImmunodiagnostic Systems Limited·2023-08-18
• K111335 — ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321Tosoh Bioscience, Inc.·2011-12-01
• K060585 — ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTHRoche Diagnostics Corp.·2006-05-03
• K050748 — ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011Scantibodies Laboratory, Inc.·2005-05-20
• K021032 — ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100Scantibodies Laboratory, Inc.·2002-06-03
• K002638 — FUTURE DIAGNOSTICS B.V. STAT-ACTH KITFuture Diagnostics B.V.·2001-01-17
• K982608 — SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KITSangui Biotech, Inc.·1998-08-19
• K962601 — NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONENichols Institute Diagnostics·1996-12-24
• K960491 — MICRO HAEMATOCRIT CENTRIFUGEHawksley & Sons , Ltd.·1996-10-18
• K960066 — IMMULITE ACTHDiagnostic Products Corp.·1996-02-16
• K940271 — INCSTAR ACTH IRMAIncstar Corp.·1994-08-02
• K926396 — ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCTNichols Institute·1993-07-27
• K915727 — ACTH IRMA KIT II MITSUBISHI YUKAMitsubishi Yuka America, Inc.·1992-03-02
• K910178 — ACTH IRMA KIT MITSUBISHI YUKAScience Regulatory Services Intl.·1991-05-22
• K900147 — MODIFIED DSL-2300 ACTH RIADiagnostic Systems Laboratories, Inc.·1990-03-01
• K882741 — ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBESNichols Institute Diagnostics·1988-08-30
• K860311 — ACTHK-PR RIA KITCompagnie Oris Industrie, S.A.·1986-04-07
• K850053 — BACI 6 -ADRENOCORTICOTROOP HORMONEEuro-Diagnostics BV·1985-04-08
• K850882 — ACTH II BY RADIOIMMUNOASSAYImmuno Nuclear Corp.·1985-03-21
• K844181 — ACTH RIASyncor Intl. Corp.·1984-11-27
• K842249 — ACTH NORMAL RANGEDiagnostic Systems Laboratories, Inc.·1984-08-15
• K833934 — ADRENOCORTICOTROPIC HORMONE TESTClinetics Corp.·1984-04-04
• K840018 — DPC ACTH KITDiagnostic Products Corp.·1984-03-23
• K833849 — ACTH RIASyncor Intl. Corp.·1984-01-30
• K833471 — ADRENOCOR TICOTROPIC HORMONE RADIOIMMNichols Institute Diagnostics·1984-01-11
• K831855 — HATCH KITRadioassay Systems Laboratories, Inc.·1983-07-28
• K831826 — ADRENOCORTICOTROPIN RADIO-IMMUNOASSAYDamon Corp.·1983-07-18
• K830893 — ACTH RIA SYSTEM-DSI 2300Diagnostic Systems Laboratories, Inc.·1983-04-27
• K822115 — SERAGAN ACTH125 I-RIA KITSeragen Diagnostics, Inc.·1982-10-18
• K811565 — ACTH RADIOIMMUNOASSAY KITImmuno Nuclear Corp.·1981-06-25