FDA 510(k) Premarket Notification K761345: GLUCO-HEX TM REAGENT KIT

Submission Details & Decision

Normalized public record details for 510(k) notification K761345.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K761345

Applicant / Sponsor

J.T. Baker Chemical Co.

Device Name

GLUCO-HEX TM REAGENT KIT

Product Code

CFR

Decision Date

1977-01-05

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

1976-12-28

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