510(k) K791711
K791711 is an FDA 510(k) premarket notification submitted by Carr-Scarborough Microbiologicals, Inc. for the device "IMPROVED GRAM STAIN REAGENTS". The FDA issued a decision of Substantially Equivalent on Oct 17, 1979. The device falls under product code HYI (Iodine, Grams), a Class I device regulated under 21 CFR 864.1850. Carr-Scarborough Microbiologicals, Inc. has 23 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 17, 1979
- Date Received
- Aug 28, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Iodine, Grams
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- PA
- Submission Type
- 510(k) Exempt