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510(k) K832088

AMES TDA NETILMICIN TEST & SERUM by Miles Laboratories, Inc. — Product Code LCE

K832088 is an FDA 510(k) premarket notification submitted by Miles Laboratories, Inc. for the device "AMES TDA NETILMICIN TEST & SERUM". The FDA issued a decision of Substantially Equivalent on October 28, 1983. The device falls under product code LCE (Radioimmunoassay, Netilmicin (I-125)), 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
October 28, 1983
Date Received
June 28, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Netilmicin (I-125)
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 LCE

  • K833715 — EMIT NETILMICIN ASSAY (December 27, 1983)
  • K822941 — NETILMICIN FLUORESCENT IMMUNOASSAY (October 26, 1982)
  • K821698 — TDX NETILMICIN (June 22, 1982)
  • K821399 — MACRO-VUE CARD TEST, NETILMICIN (May 28, 1982)
  • K820324 — EMIT AND NETILMICIN ASSAY (February 23, 1982)

FDA data resources