FDA 510(k) Premarket Notification K971921: PROLACTIN (PRL) HORMONE MICROPLATE ELISA

Submission Details & Decision

Normalized public record details for 510(k) notification K971921.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K971921

Applicant / Sponsor

Monobind

Device Name

PROLACTIN (PRL) HORMONE MICROPLATE ELISA

Product Code

CFT

Decision Date

1997-06-24

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

1997-05-23

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