Home / 510(k) Clearances / K830701

510(k) K830701

STRATUS PHENOBARBITAL FLUOROMETRIC ENZ by American Dade — Product Code LET

K830701 is an FDA 510(k) premarket notification submitted by American Dade for the device "STRATUS PHENOBARBITAL FLUOROMETRIC ENZ". The FDA issued a decision of Substantially Equivalent on May 13, 1983. The device falls under product code LET (Fluorescent Immunoassay, Phenobarbital), a Class II device regulated under 21 CFR 862.3660. American Dade has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1983
Date Received
March 7, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescent Immunoassay, Phenobarbital
Device Class
Class II
Regulation Number
862.3660
Review Panel
TX
Submission Type

Other clearances by American Dade

  • K873051 — STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY (October 20, 1987)
  • K873171 — STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY (September 29, 1987)
  • K873052 — STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY (September 14, 1987)
  • K872789 — PARAMAX URINE/CSF CALIBRATOR (September 2, 1987)
  • K872195 — DATA-FI DIMERTEST LATEX ASSAY (August 6, 1987)
  • K872196 — AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III (July 31, 1987)
  • K871972 — STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY (July 21, 1987)
  • K871977 — DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR (July 9, 1987)
  • K872050 — PARAMAX CHOLESTEROL REAGENT (July 7, 1987)
  • K872360 — DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET (July 6, 1987)

Other clearances for product code LET

  • K901537 — MODIFIED OPUS PHENOBARBITAL TEST SYSTEM (June 12, 1990)
  • K865000 — IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS (February 6, 1987)
  • K842592 — AMES TDA PHENOBARBITAL TEST (August 17, 1984)
  • K821408 — PHENOBARBITAL FLUORESCENT IMMUNO (May 24, 1982)
  • K820188 — PHENOBARBITAL ASSAY (February 5, 1982)
  • K810994 — AMES TDA TM PHENOBARBITAL TEST (April 29, 1981)
  • K802255 — AMES TDA PHENOBARBITAL TEST (September 26, 1980)

FDA data resources