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510(k) K992452

RAPIDONE-AMPHETAMINE TEST by American Bio Medica Corp. — Product Code DOD

K992452 is an FDA 510(k) premarket notification submitted by American Bio Medica Corp. for the device "RAPIDONE-AMPHETAMINE TEST". The FDA issued a decision of Substantially Equivalent on October 18, 1999. The device falls under product code DOD (Gas Chromatography, Amphetamine), a Class II device regulated under 21 CFR 862.3100. American Bio Medica Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1999
Date Received
July 22, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Chromatography, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

Other clearances by American Bio Medica Corp.

  • K170222 — Rapid Tox Cup II (August 15, 2017)
  • K073078 — RAPID TOX CUP (May 30, 2008)
  • K060760 — RAPIDONE-BUPRENORPHINE TEST (August 7, 2006)
  • K053422 — RAPIDONE-COCAINE-150 TEST (June 15, 2006)
  • K053359 — RAPIDTOX (May 25, 2006)
  • K041696 — RAPID READER (July 12, 2005)
  • K041712 — 'RAPIDTEC 4' TEST (November 3, 2004)
  • 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)

FDA data resources