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510(k) K820683

STAPHYLOCOCCUS LATEX AGGLUTINATION KIT by American Scientific Products — Product Code LHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1982
Date Received
March 11, 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 American Scientific Products

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  • K831626 — UREA NITROGEN-BUN-REAGENTS B6370-11A (July 7, 1983)
  • K831625 — UREA NITROGEN-BUN-REAGENTS B6360-12 (July 7, 1983)
  • K831628 — CREATININE REAGENTS B6370-13 (July 6, 1983)
  • K831624 — GLUCOSE REAGENT KITS-B6370-10A (July 6, 1983)
  • K831627 — CREATININE REAGENTS B6360-10 (July 6, 1983)
  • K831569 — REAGENT CUPS (June 30, 1983)
  • K831571 — ROTOR (June 30, 1983)

Other clearances for product code LHT

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  • K820347 — ACCU-STAPH (March 4, 1982)
  • K812434 — DIAGNOSTIC KITS & KIT COMPONENTS (September 23, 1981)
  • K812372 — GUINEA PIG BLOOD IN ALSEVER'S, CIT., DEF (September 9, 1981)
  • K812373 — RABBIT BLOOD IN ALSEVER'S, CITR., DEFIBR (September 9, 1981)
  • K812375 — BABY CHICK BLOOD IN ALSEVER'S (September 9, 1981)
  • K812368 — RAT BLOOD IN ALSEVER'S, CITRATED (September 9, 1981)
  • K812367 — GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD) (September 9, 1981)