510(k) K874757
K874757 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III". The FDA issued a decision of Substantially Equivalent on Feb 2, 1988. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 2, 1988
- Date Received
- Nov 18, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Drug Mixture Control Materials
- Device Class
- Class I
- Regulation Number
- 862.3280
- Review Panel
- TX
- Submission Type
- 510(k) Exempt