SCHIFF REAGENT FUCHSIN-SULFUROUS ACID
FDA 510(k) clearance K842919 · decided 1984-09-11
Clearance details
- K-number
- K842919
- Device name
- SCHIFF REAGENT FUCHSIN-SULFUROUS ACID
- Applicant
- E K Ind., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-07-25
- Decision date
- 1984-09-11
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- HZT
- Device class
- 1
- Regulation number
- 864.1850
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Walker, MI, 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 |
|---|---|---|
| SCHIFF REAGENT (K883217) | Surgipath Medical Industries, Inc. | 1988-08-05 |
| SIGMA PERIODIC ACID-SCHIFF STAIN 395 (K843752) | Sigma Chemical Co. | 1984-10-30 |
| SCHIFF REAGENT, PAS STAIN (K842917) | E K Ind., Inc. | 1984-09-07 |
| HISTOCHEMICAL PAS REACTION SET (K760031) | Harleco | 1976-07-20 |
Recalls involving this device
No recalls on record reference this clearance.