510(k) K900343
K900343 is an FDA 510(k) premarket notification submitted by Biomerica, Inc. for the device "GAP-IGG". The FDA issued a decision of Substantially Equivalent on August 22, 1991. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. Biomerica, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 1991
- Date Received
- January 23, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Helicobacter Pylori
- Device Class
- Class I
- Regulation Number
- 866.3110
- Review Panel
- MI
- Submission Type