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510(k) K041712

'RAPIDTEC 4' TEST by American Bio Medica Corp. — Product Code DIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2004
Date Received
June 23, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Barbiturate
Device Class
Class II
Regulation Number
862.3150
Review Panel
TX
Submission Type

Other clearances by American Bio Medica Corp.

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  • K030835 — 'RAPID ONE' - PROPOXYPHENE TEST (May 22, 2003)
  • K023869 — 'RAPIDTEC'-5M-MULTIPLE DIP TEST (April 30, 2003)
  • K021114 — 'RAPIDTEC' 5A MULTIPLE DIP TEST (July 23, 2002)
  • K014101 — RAPIDONE-OXY TEST (March 20, 2002)

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  • K070098 — QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREEN (December 7, 2007)
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