Doa - Immunoassay Cut-Off Calibrator
FDA 510(k) K945289 · Medi-Tech, Inc.
510(k) numberK945289
Submission
- Device name
- Doa - Immunoassay Cut-Off Calibrator
- Applicant
- Medi-Tech, Inc.
Ventura, CA, US - Received
- October 31, 1994
- Decision date
- December 13, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DKB – Calibrators, Drug Mixture
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3200
- Specialty
- Clinical Toxicology
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Questions and answers
When was Doa - Immunoassay Cut-Off Calibrator cleared by the FDA?
Doa - Immunoassay Cut-Off Calibrator (K945289) received a 510(k) decision of Substantially Equivalent on December 13, 1994, 43 days after the submission was received.
What is the product code of K945289?
The FDA product code is DKB – Calibrators, Drug Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.3200.