GRAMSTAIN SET
FDA 510(k) clearance K821977 · decided 1982-07-22
Clearance details
- K-number
- K821977
- Device name
- GRAMSTAIN SET
- Applicant
- Granite Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-07-06
- Decision date
- 1982-07-22
- Days to decision
- 16 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
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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 |
| PARA-PAK (K811722) | Meridian Diagnostics, Inc. | 1981-07-15 |
| IMPROVED GRAM STAIN REAGENTS (K791711) | Carr-Scarborough Microbiologicals, Inc. | 1979-10-17 |
| GRAM STAIN KIT (K781584) | Bioscientific | 1978-10-10 |
Recalls involving this device
No recalls on record reference this clearance.