Immunosuppressant (Whole Blood) Control, Level 1 250-1, Immunosuppressant (Whole Bloos) Control, Level 2, 250-2, Immun\S
FDA 510(k) K980331 · More Diagnostics
510(k) numberK980331
Submission
- Device name
- Immunosuppressant (Whole Blood) Control, Level 1 250-1, Immunosuppressant (Whole Bloos) Control, Level 2, 250-2, Immun\S
- Applicant
- More Diagnostics
Los Osos, CA, US - Received
- January 28, 1998
- Decision date
- March 16, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 Immunosuppressant (Whole Blood) Control, Level 1 250-1, Immunosuppressant (Whole Bloos) Control, Level 2, 250-2, Immun\S cleared by the FDA?
Immunosuppressant (Whole Blood) Control, Level 1 250-1, Immunosuppressant (Whole Bloos) Control, Level 2, 250-2, Immun\S (K980331) received a 510(k) decision of Substantially Equivalent on March 16, 1998, 47 days after the submission was received.
What is the product code of K980331?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.