510(k) K772105
K772105 is an FDA 510(k) premarket notification submitted by Streck Laboratories, Inc. for the device "PLATELET KIT". The FDA issued a decision of Substantially Equivalent on November 30, 1977. The device falls under product code GLG (Platelet Counting, Manual), a Class I device regulated under 21 CFR 864.6160. Streck Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 1977
- Date Received
- November 7, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Platelet Counting, Manual
- Device Class
- Class I
- Regulation Number
- 864.6160
- Review Panel
- HE
- Submission Type