'Rapid Drug Screen' 8 Panel-Low Volume
FDA 510(k) K981705 · American Bio Medica Corp.
510(k) numberK981705
Submission
- Device name
- 'Rapid Drug Screen' 8 Panel-Low Volume
- Applicant
- American Bio Medica Corp.
Washington, DC, US - Received
- May 14, 1998
- Decision date
- August 27, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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| K030835 | 'Rapid One' - Propoxyphene TestJXN · Traditional | 05/22/2003SE |
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Questions and answers
When was 'Rapid Drug Screen' 8 Panel-Low Volume cleared by the FDA?
'Rapid Drug Screen' 8 Panel-Low Volume (K981705) received a 510(k) decision of Substantially Equivalent on August 27, 1998, 105 days after the submission was received.
What is the product code of K981705?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.