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510(k) K832792

AMES TDA SISOMICIN TEST-CONTROL SERUM by Miles Laboratories, Inc. — Product Code DJB

K832792 is an FDA 510(k) premarket notification submitted by Miles Laboratories, Inc. for the device "AMES TDA SISOMICIN TEST-CONTROL SERUM". The FDA issued a decision of Substantially Equivalent on September 29, 1983. The device falls under product code DJB (Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.), a Class II device regulated under 21 CFR 862.3450. Miles Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1983
Date Received
August 16, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
Device Class
Class II
Regulation Number
862.3450
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)
  • K865053 — SERA-TEK MICROSOMAL ANTIBODY TEST (February 18, 1987)

Other clearances for product code DJB

  • K831210 — GENTAMICIN TEST PACK-ACA (May 25, 1983)
  • K821669 — AMES TDA GENTAMICIN TEST (December 15, 1982)
  • K812394 — MRI GENTAMICIN RIA KIT (September 8, 1981)
  • K811844 — COAT-A-COUNT GENTAMICIN RIA KIT (July 10, 1981)
  • K800537 — GAMMA STICK GENTAMICIN RIA KIT (April 24, 1980)
  • K791770 — QUANTIMUNE GENTAMICIN RIA GENTAMICIN (October 17, 1979)
  • K791547 — FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY (October 12, 1979)
  • K782049 — BIOASSAY SYSTEM, MS-2 SERUM (August 28, 1979)
  • K790584 — AMES TDA/GENTGMICIN (June 15, 1979)
  • K790829 — EMIT GENTAMICIN ASSAY (May 15, 1979)

FDA data resources