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510(k) K820347

ACCU-STAPH by Carr-Scarborough Microbiologicals, Inc. — Product Code LHT

K820347 is an FDA 510(k) premarket notification submitted by Carr-Scarborough Microbiologicals, Inc. for the device "ACCU-STAPH". The FDA issued a decision of Substantially Equivalent on March 4, 1982. The device falls under product code LHT (Staphylococcus Aureus Somatic Antigens), a Class I device regulated under 21 CFR 866.3700. Carr-Scarborough Microbiologicals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1982
Date Received
February 8, 1982
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 Carr-Scarborough Microbiologicals, Inc.

  • K944554 — BRAIN HEART INFUSION AGAR (October 4, 1994)
  • K941985 — MUELLER HINTON AGAR W/OXACILLIN (August 24, 1994)
  • K905472 — LAP DISCS (February 27, 1991)
  • K905666 — M. CAT. BUTYRATE DISC (February 26, 1991)
  • K891476 — C. ALBICANS SCREEN (April 12, 1989)
  • K882636 — ALN DISCS (February 16, 1989)
  • K882630 — PRO DISCS (February 16, 1989)
  • K863216 — NEIS NZY (September 15, 1986)
  • K860301 — RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE (February 6, 1986)
  • K860302 — PYR DISCS (February 5, 1986)

Other clearances for product code LHT

  • K874303 — STAPHYLASE TEST (November 6, 1987)
  • K863025 — SERO-STAT R II STAPHYLOCOCCUS TEST (September 15, 1986)
  • K820531 — ENDO-STAPH TEICHOIC ACID ANTIBODY KIT (April 14, 1982)
  • K820683 — STAPHYLOCOCCUS LATEX AGGLUTINATION KIT (April 14, 1982)
  • K812434 — DIAGNOSTIC KITS & KIT COMPONENTS (September 23, 1981)
  • K812368 — RAT BLOOD IN ALSEVER'S, CITRATED (September 9, 1981)
  • K812373 — RABBIT BLOOD IN ALSEVER'S, CITR., DEFIBR (September 9, 1981)
  • K812374 — ADULT CHICKEN BLOOD IN ALSEVER'S, C., D. (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)

FDA data resources