510(k) K972576
K972576 is an FDA 510(k) premarket notification submitted by Accumed Intl., Inc. for the device "GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90". The FDA issued a decision of Substantially Equivalent on Jan 22, 1998. The device falls under product code LQL (Gram Positive Identification Panel), a Class I device regulated under 21 CFR 866.2660. Accumed Intl., Inc. has 11 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 22, 1998
- Date Received
- Jul 10, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Gram Positive Identification Panel
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type
- 510(k) Exempt