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

Ph Rate Measurement, Carbon-Dioxide

21 CFR 862.1160 / Clinical Chemistry
FDA source (opens on fda.gov)

JFL is the FDA product code for Ph Rate Measurement, Carbon-Dioxide, a class II device type, regulated under 21 CFR 862.1160. As of , FDA records hold 28 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
JFL
Device name
Ph Rate Measurement, Carbon-Dioxide
Regulation
21 CFR 862.1160
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
28
Ingested recalls
3

Clearances, product code JFL

By decision year
28 clearances under product code JFL with a decision year between 1977 and 2020, 1993 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code JFL by decision year
YearClearances
19771
19793
19803
19811
19822
19841
19871
19903
19935
19941
19964
20011
20041
20201

Applicants with the most clearances

Product code JFL
Applicants holding the most 510(k) clearances under product code JFL
ApplicantClearances
Sigma Chemical Co.4
Sigma Diagnostics, Inc.3
American Research Products Co.2
Hi Chem, Inc.2
Hichem Diagnostics2
Nova Biomedical Corporation2
A-Kem, Inc.1
Abbott Medical1
Siemens Healthcare Diagnostics Inc.1
Beckman Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code