510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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JKSClass I

Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide

21 CFR 862.3220 / Clinical Toxicology
FDA source (opens on fda.gov)

JKS is the FDA product code for Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide, a class I device type, regulated under 21 CFR 862.3220. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
JKS
Device name
Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
Regulation
21 CFR 862.3220
Device class
Class I
Review panel
Clinical Toxicology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
1

Clearances, product code JKS

By decision year
8 clearances under product code JKS with a decision year between 1978 and 1995, 1983 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JKS by decision year
YearClearances
19781
19833
19851
19862
19951

Applicants with the most clearances

Product code JKS
Applicants holding the most 510(k) clearances under product code JKS
ApplicantClearances
A-Vox Systems, Inc.1
Neogen Culture Media1
Bio-Nustics, Inc.1
D.R.G. Scientific Industries1
Instrumentation Laboratory Co.1
Radiometer America, Inc1
Shaban Mfg. Co.1
The London Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code