Product code CGR— Clinical Chemistry
CENTRIA CORTISOL RIA
- Classification name
- Radioimmunoassay, Cortisol
- Device class
- Class 2
- Regulation
- 21 CFR 862.1205
- Advisory panel
- Clinical Chemistry
- Total cleared
- 84
- First cleared
- Most recent
Market context for product code CGR
FDA has cleared devices under product code CGR between 1976 and 2025, filed by 57 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.
Clearances per year
last 15 years- 2025
- 2023
- 2021
- 2006
- 2005
- 2004
- 2002
- 1999
- 1998
- 1997
- 1995
- 1994
- 1993
- 1992
- 1991
Top applicants under product code CGR
Recent clearances under product code CGR
- K242190 — Access Cortisol; DxC 500i Clinical Analyzer
- K223038 — Access Cortisol
- K202136 — IDS Cortisol
- K202826 — IMMULITE® 2000 Cortisol
- K203270 — IMMULITE/IMMULITE® 1000 Cortisol
- K062626 — CORTISOL ELISA
- K060480 — VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS
- K052359 — IBL CORTISOL LIA TEST KIT
- K050202 — CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
- K042689 — NICHOLS ADVANTAGE CORTISOL
- K010790 — CORTISOL LIA
- K984520 — NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005
- K983990 — VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY
- K962208 — NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT
- K954733 — ACCESS CORTISOL ASSAY (MODIFICATION)
- K945367 — CIBA CORNING ACS CORTISOL IMMUNOASSAY
- K943427 — ACE CEDIA CORTISOL ASSAY
- K940221 — ACCESS CORTISOL REAGENTS
- K931177 — SYNELISA CORTISOL
- K931409 — IMMULITE CORTISOL
- K922676 — CORTISOL CHEMILUMINESCENCE ASSAY
- K914886 — SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)
- K905473 — UBI MAGIWEL CORTISOL QUANTITATIVE
- K903975 — SEROZYME CORTISOL TEST KIT
- K900485 — ENZYMUN TEST(R) CORTISOL
- K901296 — CEDIA (TM) CORTISOL ASSAY
- K896451 — MODIFIED CEDIA(TM) CORTISOL ASSAY
- K895006 — MILENIA(TM) CORTISOL (MKCO1,5)
- K895407 — CORTISOL CLASP-BEAD EIA KIT
- K884689 — DSL 7800 ACTIVE CORTISOL
- K880687 — CORTISOL ENHANCED LUMINESCENCE ASSAY KIT
- K870969 — CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT
- K872177 — TIPSEP-CORTISOL RIA DIAGNOSTIC KIT
- K862336 — PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT
- K862871 — RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL
- K852939 — CORTISOL SYSTEM BY EIA
- K850141 — ACTIVE CORTISOL DSL 2000-SP
- K850008 — SOPHEIA/MP CORTISOL EIA KIT
- K843384 — LEECO CORTISOL-QUANT
- K843183 — STRATUS CORTISOL FLUOROMETRIC ENZYME
- K842957 — CORITSOL PREMIX RIA KIT
- K841641 — CORNING MAGIC CORTISOL RADIOIMMUNO
- K842365 — CORTI-COTE CORTISOL SOLID PHASE RADIO
- K842455 — AMER. BIO-SCIENCE LAB CORTISOL REAGENT
- K842554 — IMMPULSE CORTISOL ASSAY REAGENTS
- K840466 — NML CORTISOL RIA
- K834219 — PHASE II CORTISOL KIT
- K832638 — CORTISOL RADIOIMMUNOASSAY KIT
- K831141 — EMIT SRD MANUAL CORTISOL ASSAY
- K830563 — CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK
- K830148 — CORTISOL KIT
- K822892 — CORTISOL RIA KIT
- K822845 — SOPHEIA CORTISOL EIA KIT
- K821931 — ZETA-CORT
- K821068 — DSL 1020
- K820341 — CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT
- K820074 — CORTISOL (RIA) KIT
- K810891 — COAT-A-COUNT CORTISOL RIA KIT
- K810192 — ENDAB CORTISOL KIT
- K810033 — CORTI-SHURE
- K802969 — CORTISOL 125-I RADIOIMMUNOASSAY KIT
- K802380 — ARIA II 125 I CORTISOL
- K802036 — CORTISOL125 RADIOIMMUNOASSAY
- K801203 — CORTISOL RADIOIMMUNOASSAY KIT
- K800538 — GAMMA STICK CORTISOL RIA KIT/STICK KIT
- K800700 — AMERLEX CORTISOL RIA KIT
- K800594 — VENTRE/SEP CORTISOL RIA
- K800245 — EMIT AUTO CORTISOL ASSAY
- K800045 — QUANTIMUNE CORTISOL RIA CORTISOL RADIO-
- K792439 — ANALYTE CORTISOL
- K792243 — CENTRIA CORTISOL RIA TEST SET
- K792036 — CORTISOL RADIOIMMUNOASSAY SYSTEM
- K791700 — CORTI-SHURE
- K791835 — CORALENT COAT 125I CORTISOL RADIOIMM.
- K790906 — AUTOPAK CORTISOL TEST DELIVERY SYSTEM
- K790268 — CORTISOL RIA KIT
- K781903 — RIA KIT, QUANTITOPE CORTISOL
- K782110 — RIA KIT, RIANEN CORTISOL
- K781730 — RIA, CORTISOL KIT
- K780725 — CENTRIA CORTISOL RIA
- K771117 — CENTRIA CORTISOL RIA
- K761346 — RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA)
- K760939 — CORTISOL REAGENT SYSTEM
- K760256 — TEST SYSTEM, RIA CORTISOL
Data sourced from openFDA. This site is unofficial and independent of the FDA.