IMPROVED GRAM STAIN REAGENTS
FDA 510(k) clearance K791711 · decided 1979-10-17
Clearance details
- K-number
- K791711
- Device name
- IMPROVED GRAM STAIN REAGENTS
- Applicant
- Carr-Scarborough Microbiologicals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-08-28
- Decision date
- 1979-10-17
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- HYI
- Device class
- 1
- Regulation number
- 864.1850
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Carr-Scarborough Microbiologicals
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GRAM IODINE (K871286) | Remel Co. | 1987-04-08 |
| GRAM IODINE (K842733) | E K Ind., Inc. | 1984-08-10 |
| GRAMSTAIN SET (K821977) | Granite Diagnostics, Inc. | 1982-07-22 |
| PARA-PAK (K811722) | Meridian Diagnostics, Inc. | 1981-07-15 |
| GRAM STAIN KIT (K781584) | Bioscientific | 1978-10-10 |
Recalls involving this device
No recalls on record reference this clearance.