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510(k) K863025

SERO-STAT R II STAPHYLOCOCCUS TEST by Scott Laboratories, Inc. — Product Code LHT

K863025 is an FDA 510(k) premarket notification submitted by Scott Laboratories, Inc. for the device "SERO-STAT R II STAPHYLOCOCCUS TEST". The FDA issued a decision of Substantially Equivalent on September 15, 1986. The device falls under product code LHT (Staphylococcus Aureus Somatic Antigens), a Class I device regulated under 21 CFR 866.3700. Scott Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1986
Date Received
August 11, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staphylococcus Aureus Somatic Antigens
Device Class
Class I
Regulation Number
866.3700
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)
  • K852869 — SELECTICULT-CHLAMYDIA (September 19, 1985)
  • K852832 — IDENTICULT-NEISSERIA (July 19, 1985)
  • K852666 — IDENTICULT-AE (July 15, 1985)
  • K841680 — SCOTT SELECTICULT-HSV ISOLATION & (October 30, 1984)
  • K811098 — SERO-STAT STAPHYLOCOCCUS TEST (May 5, 1981)

Other clearances for product code LHT

  • K874303 — STAPHYLASE TEST (November 6, 1987)
  • K820531 — ENDO-STAPH TEICHOIC ACID ANTIBODY KIT (April 14, 1982)
  • K820683 — STAPHYLOCOCCUS LATEX AGGLUTINATION KIT (April 14, 1982)
  • K820347 — ACCU-STAPH (March 4, 1982)
  • K812434 — DIAGNOSTIC KITS & KIT COMPONENTS (September 23, 1981)
  • K812373 — RABBIT BLOOD IN ALSEVER'S, CITR., DEFIBR (September 9, 1981)
  • K812367 — GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD) (September 9, 1981)
  • K812376 — SHEEP BLOOD IN ALSEVER'S, CITR., DEFIBR (September 9, 1981)
  • K812375 — BABY CHICK BLOOD IN ALSEVER'S (September 9, 1981)
  • K812372 — GUINEA PIG BLOOD IN ALSEVER'S, CIT., DEF (September 9, 1981)

FDA data resources