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510(k) K781108

MICROCULT-GC CULTURE TEST by Miles Laboratories, Inc. — Product Code JSX

K781108 is an FDA 510(k) premarket notification submitted by Miles Laboratories, Inc. for the device "MICROCULT-GC CULTURE TEST". The FDA issued a decision of Substantially Equivalent on August 31, 1978. The device falls under product code JSX (Kit, Identification, Neisseria Gonorrhoeae), a Class I device regulated under 21 CFR 866.2660. Miles Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1978
Date Received
June 30, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Identification, Neisseria Gonorrhoeae
Device Class
Class I
Regulation Number
866.2660
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 JSX

  • K960759 — GONOPOX TEST KIT (September 18, 1996)
  • K923566 — NIZYME TEST KIT (November 2, 1992)
  • K913456 — VISI-NEISSERIA (October 11, 1991)
  • K880511 — XACT NEISSERIA (August 25, 1988)
  • K881501 — MODIFIED IDS RAPID NH SYSTEM (May 18, 1988)
  • K870117 — NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST (March 20, 1987)
  • K853544 — QUAD FERM + (September 5, 1985)
  • K852998 — NEISSERIA - KWIK PLUS (July 23, 1985)
  • K852582 — GONI-KIT (July 12, 1985)
  • K833307 — PHADEBACK G.C. POSITIVE CONTROLS (December 27, 1983)

FDA data resources