SERIES I/S INFECTIONS— 510(k) K844289

Substantially Equivalent

American Dade

FDA 510(k) clearance K844289 for SERIES I/S INFECTIONS, Substantially Equivalent on 1984-11-19. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
Advisory panel: Immunology
Date received: 1984-11-05
Decision date: 1984-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

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More clearances from American Dade

K873051 — STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY1987-10-20
K873171 — STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-29
K873052 — STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-14
K872789 — PARAMAX URINE/CSF CALIBRATOR1987-09-02
K872195 — DATA-FI DIMERTEST LATEX ASSAY1987-08-06

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