MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT SPECI. TEST— 510(k) K864888

Clearance details

Applicant

Syva Co.

Product code

Code LJP

Device class

Class 1

Regulation

21 CFR 866.3120

Advisory panel

Microbiology

Date received

1986-12-12

Decision date

1987-02-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Palo Alto, CA, US

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