STRATUS PHENYTOIN FLUOROMETRIC ENZYME— 510(k) K831154

Name: FDA 510(k) clearance K831154
Creator: U.S. Food and Drug Administration
Published: 1983-05-16

Substantially Equivalent

American Dade

FDA 510(k) clearance K831154 for STRATUS PHENYTOIN FLUOROMETRIC ENZYME, Substantially Equivalent on 1983-05-16. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code LES
Device class: Class 2
Regulation: 21 CFR 862.3350
Advisory panel: Clinical Toxicology
Date received: 1983-04-08
Decision date: 1983-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LES

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K865102 — IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS1987-01-13
K844990 — SYVA ADVANCE EMIT PHENYTOIN ASSAY1985-01-23
K820187 — SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY1982-02-12
K813538 — PHENYTOIN FLUORESCENT IMMUNOASSAY1981-12-31
K811025 — AMES TDA TM PHENYTOIN TEST1981-04-29

More clearances from American Dade

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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.