Product code KMS— Clinical Chemistry

FDA has cleared 5 devices under product code KMS between 1978 and 1987, filed by 5 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.

• 19872 clearances
• 19802 clearances
• 19781 clearance

• Panmed, Inc.1 clearance
• Gamma Enterprises, Inc.1 clearance
• Diagnostic Solutions, Inc.1 clearance
• Catachem, Inc.1 clearance
• American Research Products Co.1 clearance

• K872886 — CARBON DIOXIDECatachem, Inc.·1987-08-13
• K870025 — AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTSAmerican Research Products Co.·1987-03-13
• K802162 — CO2 COLOR REAGENT & CO2 SAMPLE DILUENTPanmed, Inc.·1980-10-10
• K800681 — REAGENTS FOR DETERM. CO2 IN HUMAN SERUMDiagnostic Solutions, Inc.·1980-05-30
• K780506 — CARBON DIOXIDE REAGENTSGamma Enterprises, Inc.·1978-05-03