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

Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical

21 CFR 862.1660 / Clinical Chemistry
FDA source (opens on fda.gov)

LCH is the FDA product code for Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical, a class I device type, regulated under 21 CFR 862.1660. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
LCH
Device name
Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
9
Ingested recalls
2

Clearances, product code LCH

By decision year
9 clearances under product code LCH with a decision year between 1978 and 1992, 1978 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LCH by decision year
YearClearances
19782
19802
19841
19861
19902
19921

Applicants with the most clearances

Product code LCH
Applicants holding the most 510(k) clearances under product code LCH
ApplicantClearances
American Instrument Co.1
Associated Medical Representatives1
Bionostics, Inc.1
Corning Medical & Scientific1
Cryogenic Rare Gas Laboratories, Inc.1
Equilibrated Bio Systems, Inc.1
Linear Tonometers, Inc.1
Medicor USA, Ltd.1
Norco, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code