Emit 700 Cannabinoid 100 NG Calibrator & Control
FDA 510(k) K875135 · Syva Co.
510(k) numberK875135
Submission
- Device name
- Emit 700 Cannabinoid 100 NG Calibrator & Control
- Applicant
- Syva Co.
Palo Alto, CA, US - Received
- December 14, 1987
- Decision date
- April 5, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DLJ – Calibrators, Drug Specific
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3200
- Specialty
- Clinical Toxicology
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Questions and answers
When was Emit 700 Cannabinoid 100 NG Calibrator & Control cleared by the FDA?
Emit 700 Cannabinoid 100 NG Calibrator & Control (K875135) received a 510(k) decision of Substantially Equivalent on April 5, 1988, 113 days after the submission was received.
What is the product code of K875135?
The FDA product code is DLJ – Calibrators, Drug Specific, a Class II (moderate risk) device regulated under 21 CFR 862.3200.