JKS · Class I · 21 CFR 862.3220

FDA Product Code JKS: Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-monoxide

Leading manufacturers include Acumedia Manufacturers, Inc., Shaban Mfg. Co. and Radiometer America, Inc..

8
Total
8
Cleared
90d
Avg days
1978
Since

FDA 510(k) Cleared Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-monoxide Devices (Product Code JKS)

8 devices
1–8 of 8
Cleared Jul 29, 1986
IL 482 CO-OXIMETER
K862253
Instrumentation Laboratory CO
Chemistry · 46d
Cleared Dec 30, 1985
OSM3 HEMOXIMETER
K853990
Radiometer America, Inc.
Chemistry · 94d
Cleared Dec 30, 1983
TEE ADAPTER 9890-FLUSH WINDING 282
K833693
Shaban Mfg. Co.
Chemistry · 73d
Cleared Oct 27, 1983
BILE SALTS MIXTURE
K833211
Acumedia Manufacturers, Inc.
Microbiology · 38d

About Product Code JKS - Regulatory Context