510(k) K920223
K920223 is an FDA 510(k) premarket notification submitted by Streck Laboratories, Inc. for the device "CHEM CHEX THEOPHYLLINE CONTROL". The FDA issued a decision of Substantially Equivalent on June 10, 1992. The device falls under product code LAW (Theophylline Control Materials), a Class I device regulated under 21 CFR 862.3280. Streck Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 1992
- Date Received
- January 17, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Theophylline Control Materials
- Device Class
- Class I
- Regulation Number
- 862.3280
- Review Panel
- TX
- Submission Type