STC Methamphetamine Micro-Plate Eia
FDA 510(k) K972989 · OraSure Technologies, Inc.
510(k) numberK972989
Submission
- Device name
- STC Methamphetamine Micro-Plate Eia
- Applicant
- OraSure Technologies, Inc.
Bethlehem, PA, US - Received
- August 12, 1997
- Decision date
- January 28, 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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| K000399 | STC PCP Intercept Micro-Plate Eia, Model 11541LCM · Traditional | 05/15/2000SE |
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Questions and answers
When was STC Methamphetamine Micro-Plate Eia cleared by the FDA?
STC Methamphetamine Micro-Plate Eia (K972989) received a 510(k) decision of Substantially Equivalent on January 28, 1998, 169 days after the submission was received.
What is the product code of K972989?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.