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510(k) K820531

ENDO-STAPH TEICHOIC ACID ANTIBODY KIT by Meridian Diagnostics, Inc. — Product Code LHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1982
Date Received
March 2, 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

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Other clearances for product code LHT

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  • K820683 — STAPHYLOCOCCUS LATEX AGGLUTINATION KIT (April 14, 1982)
  • K820347 — ACCU-STAPH (March 4, 1982)
  • K812434 — DIAGNOSTIC KITS & KIT COMPONENTS (September 23, 1981)
  • K812368 — RAT BLOOD IN ALSEVER'S, CITRATED (September 9, 1981)
  • K812367 — GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD) (September 9, 1981)
  • K812375 — BABY CHICK BLOOD IN ALSEVER'S (September 9, 1981)
  • K812373 — RABBIT BLOOD IN ALSEVER'S, CITR., DEFIBR (September 9, 1981)
  • K812376 — SHEEP BLOOD IN ALSEVER'S, CITR., DEFIBR (September 9, 1981)