CARBON DIOXIDE REAGENTS— 510(k) K780506

Name: FDA 510(k) clearance K780506
Creator: U.S. Food and Drug Administration
Published: 1978-05-03

Substantially Equivalent

Gamma Enterprises, Inc.

FDA 510(k) clearance K780506 for CARBON DIOXIDE REAGENTS, Substantially Equivalent on 1978-05-03. Applicant: Gamma Enterprises, Inc.. Device class: 2.

Clearance details

Applicant: Gamma Enterprises, Inc.
Product code: Code KMS
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 1978-03-30
Decision date: 1978-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code KMS

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K872886 — CARBON DIOXIDE1987-08-13
K870025 — AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS1987-03-13
K802162 — CO2 COLOR REAGENT & CO2 SAMPLE DILUENT1980-10-10
K800681 — REAGENTS FOR DETERM. CO2 IN HUMAN SERUM1980-05-30

More clearances from Gamma Enterprises, Inc.

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K790578 — GAMMA SMAC REAGENTS1979-05-15
K780504 — CREATINE PHOSPHOKINASE (CPK)1978-05-03
K780505 — SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE1978-05-03
K780507 — SERUM GLUTAMIC-PYRUVIC TRANSAMINASE1978-05-03
K771832 — CHLORIDE1977-11-22

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