FDA 510(k) Premarket Notification K760096: REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O

Submission Details & Decision

Normalized public record details for 510(k) notification K760096.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K760096

Applicant / Sponsor

Gamma Biologicals, Inc.

Device Name

REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O

Product Code

GTQ

Decision Date

1976-08-03

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Microbiology (MI)

Clearance Type

Traditional

Third Party Flag

Date Received

1976-06-14

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