Stratus(R) Immunoassay Controls Levels I, II, III
FDA 510(k) K874757 · Baxter Healthcare Corp
510(k) numberK874757
Submission
- Device name
- Stratus(R) Immunoassay Controls Levels I, II, III
- Applicant
- Baxter Healthcare Corp
Miami, FL, US - Received
- November 18, 1987
- Decision date
- February 2, 1988
- 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 Stratus(R) Immunoassay Controls Levels I, II, III cleared by the FDA?
Stratus(R) Immunoassay Controls Levels I, II, III (K874757) received a 510(k) decision of Substantially Equivalent on February 2, 1988, 76 days after the submission was received.
What is the product code of K874757?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.