POLYCHROME IV STAIN
FDA 510(k) clearance K854176 · decided 1985-10-31
Clearance details
- K-number
- K854176
- Device name
- POLYCHROME IV STAIN
- Applicant
- Devetec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-10-15
- Decision date
- 1985-10-31
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- LED
- Device class
- 1
- Regulation number
- 864.1850
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Bradenton, FL, 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 |
|---|---|---|
| SLIVASURE (K051409) | Scandinavian Formulas, Inc. | 2005-08-08 |
| SST SALIVA SUPPORTING TABLETS (K023046) | Sinclair Pharmaceuticals, Ltd. | 2002-12-02 |
| SPOTTEST CALCOFLUOR WHITE REAGENT (K860795) | Difco Laboratories, Inc. | 1986-03-12 |
| MEGACOLOR (K860319) | Cytocolor, Inc. | 1986-02-20 |
| NEUTROCOLOR (K860317) | Cytocolor, Inc. | 1986-02-20 |
| LYSOCOLOR (K860321) | Cytocolor, Inc. | 1986-02-20 |
| GRANULOCOLOR (K860320) | Cytocolor, Inc. | 1986-02-20 |
| PANOPTIKON (K860316) | Cytocolor, Inc. | 1986-02-20 |
| SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR (K851481) | Difco Laboratories, Inc. | 1985-04-29 |
| GOMORI'S TRICHROME STAIN (K842930) | E K Ind., Inc. | 1984-09-11 |
| SUPERMOUNT (K842727) | E K Ind., Inc. | 1984-08-03 |
| PRESERV GOMORI TRICHROME STAIN 125/500 (K840087) | Preventive Diagnostics Corp. | 1984-02-10 |
Recalls involving this device
No recalls on record reference this clearance.