Bio-Rad Blind Perfor. Specimen Set for Nida Reg.
FDA 510(k) K895816 · Bio-Rad
510(k) numberK895816
Submission
- Device name
- Bio-Rad Blind Perfor. Specimen Set for Nida Reg.
- Applicant
- Bio-Rad
Anaheim, CA, US - Received
- September 29, 1989
- Decision date
- December 7, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DIF – Drug Mixture 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 Bio-Rad Blind Perfor. Specimen Set for Nida Reg. cleared by the FDA?
Bio-Rad Blind Perfor. Specimen Set for Nida Reg. (K895816) received a 510(k) decision of Substantially Equivalent on December 7, 1989, 69 days after the submission was received.
What is the product code of K895816?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.