STRATUS PHENOBARBITAL FLUOROMETRIC ENZ— 510(k) K830701

Name: FDA 510(k) clearance K830701
Creator: U.S. Food and Drug Administration
Published: 1983-05-13

Substantially Equivalent

American Dade

FDA 510(k) clearance K830701 for STRATUS PHENOBARBITAL FLUOROMETRIC ENZ, Substantially Equivalent on 1983-05-13. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code LET
Device class: Class 2
Regulation: 21 CFR 862.3660
Advisory panel: Clinical Toxicology
Date received: 1983-03-07
Decision date: 1983-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LET

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K901537 — MODIFIED OPUS PHENOBARBITAL TEST SYSTEM1990-06-12
K865000 — IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS1987-02-06
K842592 — AMES TDA PHENOBARBITAL TEST1984-08-17
K821408 — PHENOBARBITAL FLUORESCENT IMMUNO1982-05-24
K820188 — PHENOBARBITAL ASSAY1982-02-05

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

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