CYMET-PLUS— 510(k) K771716

Substantially Equivalent

J.T. Baker Chemical Co.

FDA 510(k) clearance K771716 for CYMET-PLUS, Substantially Equivalent on 1977-09-20. Applicant: J.T. Baker Chemical Co.. Device class: 2.

Clearance details

Applicant: J.T. Baker Chemical Co.
Product code: Code GKK
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1977-09-12
Decision date: 1977-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code GKK

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K894951 — MODIFIED HEMOGLOBIN REAGENT SET1989-10-24
K883992 — KVM PREPACK HEMATOLOGY REAGENT SET1988-10-12
K821202 — HEMOGLOBIN REAGENT SET1982-05-24
K771090 — UNIPAK HEMOGLOBIN1977-07-11

More clearances from J.T. Baker Chemical Co.

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K801909 — LSA 290 ASSAY REAGENTS/NEPHELOMETRIC1980-09-26
K802035 — BAKER DIAG. ULTRARATE CO2 REAGENT KIT1980-09-26
K801661 — J.T. BAKER CERULOPLASMIN NEPHELOMETRIC1980-09-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.