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510(k) K802255

AMES TDA PHENOBARBITAL TEST by Miles Laboratories, Inc. — Product Code LET

K802255 is an FDA 510(k) premarket notification submitted by Miles Laboratories, Inc. for the device "AMES TDA PHENOBARBITAL TEST". The FDA issued a decision of Substantially Equivalent on September 26, 1980. The device falls under product code LET (Fluorescent Immunoassay, Phenobarbital), a Class II device regulated under 21 CFR 862.3660. Miles Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1980
Date Received
September 16, 1980
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 Miles Laboratories, Inc.

  • K880605 — LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER (May 26, 1988)
  • K874909 — MICRO-BUMINTEST REAGENT TABLETS (April 28, 1988)
  • K875079 — MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE (April 5, 1988)
  • K871835 — GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT (December 22, 1987)
  • K872120 — SERALYZER III BLOOD CHEMISTRY ANALYZER (October 28, 1987)
  • K873304 — CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) (September 11, 1987)
  • K872634 — CUTTER PUREFLO PLUS IV FILTER (August 4, 1987)
  • K870214 — MODIFIED SALTEX REAGENT STRIPS (June 29, 1987)
  • K870752 — SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS (April 14, 1987)
  • K864530 — SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. (February 18, 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)
  • K830701 — STRATUS PHENOBARBITAL FLUOROMETRIC ENZ (May 13, 1983)
  • K821408 — PHENOBARBITAL FLUORESCENT IMMUNO (May 24, 1982)
  • K820188 — PHENOBARBITAL ASSAY (February 5, 1982)
  • K810994 — AMES TDA TM PHENOBARBITAL TEST (April 29, 1981)

FDA data resources