Product code CEE— Clinical Chemistry

FDA has cleared 25 devices under product code CEE between 1976 and 1995, filed by 20 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.

• 19951 clearance
• 19931 clearance
• 19912 clearances
• 19902 clearances
• 19892 clearances
• 19881 clearance
• 19871 clearance
• 19862 clearances
• 19843 clearances
• 19822 clearances
• 19811 clearance
• 19801 clearance
• 19783 clearances
• 19772 clearances
• 19761 clearance

• Nuclear Diagnostics, Inc.3 clearances
• Boehringer Mannheim Corp.3 clearances
• Immunotech Corp.2 clearances
• Ventrex Laboratories, Inc.1 clearance
• Technicon Instruments Corp.1 clearance
• Syncor Intl. Corp.1 clearance
• Radioimmunoassay, Inc.1 clearance
• Pharmacia, Inc.1 clearance
• Nichols Institute Diagnostics1 clearance
• Johnson & Johnson Clinical Diagnostics, Inc.1 clearance

• K952284 — AMERLITE TBG ASSAYJohnson & Johnson Clinical Diagnostics, Inc.·1995-07-26
• K930010 — ACCESS THYROID UPTAKE ASSAYBio-Rad Laboratories, Inc.·1993-06-07
• K910677 — IMMULITE(TM) T-UPTAKECirrus Diagnostics, Inc.·1991-04-29
• K905777 — MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KITImmunotech Corp.·1991-01-30
• K900240 — DELFIA TBG KITPharmacia, Inc.·1990-03-30
• K896991 — ENZYMUN TEST(R) TBKBoehringer Mannheim Corp.·1990-03-01
• K893469 — AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KITAmersham Corp.·1989-08-15
• K885034 — T-UPTAKE MICROASSAYDiamedix Corp.·1989-02-02
• K884201 — FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KITCyberfluor, Inc.·1988-12-14
• K874658 — TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C)Technicon Instruments Corp.·1987-12-18
• K862109 — ENZYMUN TEST TBGBoehringer Mannheim Corp.·1986-06-30
• K861735 — TIPSEP-TBG ASSAYNuclear Diagnostics, Inc.·1986-06-13
• K842167 — TBG RIASyncor Intl. Corp.·1984-07-09
• K842010 — THYROXINE-BINDING GLOBULIN RADIOUMMUNichols Institute Diagnostics·1984-06-25
• K841024 — VENTREZYME T4U IMMUNOASSAY T4UVentrex Laboratories, Inc.·1984-05-09
• K822684 — ENDAB THYROID UPTAKEImmunotech Corp.·1982-10-08
• K820252 — TBG DIAGNOSTIC KITDiagnostic Reagents, Inc.·1982-05-05
• K810967 — IN-VITRO TBG RADIOIMMUNOASSAY TESTClinical Assays, Inc.·1981-04-23
• K800204 — RIA PHASE TBGBoehringer Mannheim Corp.·1980-03-19
• K781225 — GLOBULIN TEST, HUMAN THYROXINE BINDINGHyland Therapeutic Div., Travenol Laboratories·1978-08-31
• K780671 — 125 I-T3 UPTAKE REAGENTRadioimmunoassay, Inc.·1978-06-06
• K780486 — STIKSEP-T3 KITNuclear Diagnostics, Inc.·1978-04-28
• K772183 — THYROID BINDING GLOBULINCorning Medical & Scientific·1977-12-20
• K771341 — SPINSEP-TBGNuclear Diagnostics, Inc.·1977-08-10
• K760134 — PROCEDURE, RA, THYROXINE BINDING PROTEINBio-Rad·1976-07-20