Emit(R) 2000 Gentamicin Assay/Calibrators
FDA 510(k) K913410 · Syva Co.
510(k) numberK913410
Submission
- Device name
- Emit(R) 2000 Gentamicin Assay/Calibrators
- Applicant
- Syva Co.
Palo Alto, CA, US - Received
- July 31, 1991
- Decision date
- September 16, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DMB – Gas Chromatography, Methadone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3620
- Specialty
- Clinical Toxicology
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Questions and answers
When was Emit(R) 2000 Gentamicin Assay/Calibrators cleared by the FDA?
Emit(R) 2000 Gentamicin Assay/Calibrators (K913410) received a 510(k) decision of Substantially Equivalent on September 16, 1991, 47 days after the submission was received.
What is the product code of K913410?
The FDA product code is DMB – Gas Chromatography, Methadone, a Class II (moderate risk) device regulated under 21 CFR 862.3620.