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510(k) K832132

SERA-TEK MYCOPLASMA ANTIBODY TEST by Miles Laboratories, Inc. — Product Code GSB

K832132 is an FDA 510(k) premarket notification submitted by Miles Laboratories, Inc. for the device "SERA-TEK MYCOPLASMA ANTIBODY TEST". The FDA issued a decision of Substantially Equivalent on September 20, 1983. The device falls under product code GSB (Antigens, Cf, All, Mycoplasma Spp.), a Class I device regulated under 21 CFR 866.3375. Miles Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1983
Date Received
July 1, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Cf, All, Mycoplasma Spp.
Device Class
Class I
Regulation Number
866.3375
Review Panel
MI
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 GSB

  • K852933 — MYCOPLASMA SPP SEROLOGICAL REAGENTS (August 1, 1985)
  • K843664 — MYCOPLASMA PNEUMONIAE (October 25, 1984)
  • K834338 — MYCOPLASMA PNEUMONIAE CF ANTIGEN (February 27, 1984)
  • K802934 — MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL (December 31, 1980)

FDA data resources