510(k) K962265
K962265 is an FDA 510(k) premarket notification submitted by Dynatech Laboratories, Inc. for the device "MLX MICROTITER PLATE LUMINOMETER". The FDA issued a decision of Substantially Equivalent on Jul 25, 1996. The device falls under product code JSE (Culture Media, Multiple Biochemical Test), a Class I device regulated under 21 CFR 866.2320. Dynatech Laboratories, Inc. has 43 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 25, 1996
- Date Received
- Jun 12, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Culture Media, Multiple Biochemical Test
- Device Class
- Class I
- Regulation Number
- 866.2320
- Review Panel
- MI
- Submission Type
- 510(k) Exempt