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510(k) K841680

SCOTT SELECTICULT-HSV ISOLATION & by Scott Laboratories, Inc. — Product Code GQL

K841680 is an FDA 510(k) premarket notification submitted by Scott Laboratories, Inc. for the device "SCOTT SELECTICULT-HSV ISOLATION &". The FDA issued a decision of Substantially Equivalent on October 30, 1984. The device falls under product code GQL (Antisera, Fluorescent, Herpesvirus Hominis 1,2), a Class II device regulated under 21 CFR 866.3305. Scott Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1984
Date Received
April 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, Herpesvirus Hominis 1,2
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

Other clearances by Scott Laboratories, Inc.

  • K880694 — B. CAT CONFIRM (June 16, 1988)
  • K874933 — MUG-INDOLE DISC (January 5, 1988)
  • K874662 — MYCO-FLUOR REAGENT A & B (November 25, 1987)
  • K873509 — IDENTICULT-BL (October 15, 1987)
  • K871238 — ANABAG (April 3, 1987)
  • K863025 — SERO-STAT R II STAPHYLOCOCCUS TEST (September 15, 1986)
  • K852869 — SELECTICULT-CHLAMYDIA (September 19, 1985)
  • K852832 — IDENTICULT-NEISSERIA (July 19, 1985)
  • K852666 — IDENTICULT-AE (July 15, 1985)
  • K811098 — SERO-STAT STAPHYLOCOCCUS TEST (May 5, 1981)

Other clearances for product code GQL

  • K091753 — ELVIS HSV ID AND D3 TYPING TEST SYSTEM (August 28, 2009)
  • K081527 — LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT (April 1, 2009)
  • K984120 — THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME L (May 26, 1999)
  • K984135 — THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME (May 26, 1999)
  • K905608 — INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 (November 7, 1991)
  • K904095 — HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING (February 1, 1991)
  • K904167 — PATHODX HERPES TYPING (December 13, 1990)
  • K902662 — BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST (July 31, 1990)
  • K902661 — BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2 (July 31, 1990)
  • K891782 — HSV-2 ELISA TEST SYSTEM (June 20, 1989)

FDA data resources