Synchron Systems 10 Ng/Ml & 40 Ng/Ml THC Urine Controls
FDA 510(k) K971210 · Beckman Instruments, Inc.
510(k) numberK971210
Submission
- Device name
- Synchron Systems 10 Ng/Ml & 40 Ng/Ml THC Urine Controls
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- April 2, 1997
- Decision date
- April 17, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LAS – Drug Specific Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
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Questions and answers
When was Synchron Systems 10 Ng/Ml & 40 Ng/Ml THC Urine Controls cleared by the FDA?
Synchron Systems 10 Ng/Ml & 40 Ng/Ml THC Urine Controls (K971210) received a 510(k) decision of Substantially Equivalent on April 17, 1997, 15 days after the submission was received.
What is the product code of K971210?
The FDA product code is LAS – Drug Specific Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.