WRIGHT-GIEMSA QUICK STAIN
FDA 510(k) clearance K842745 · decided 1984-08-10
Clearance details
- K-number
- K842745
- Device name
- WRIGHT-GIEMSA QUICK STAIN
- Applicant
- E K Ind., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-07-13
- Decision date
- 1984-08-10
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- IAF
- 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 |
|---|---|---|
| WRIGHT-GLEMSA STAIN (K890673) | Sigma Diagnostics, Inc. | 1989-02-24 |
| ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET (K890674) | Sigma Diagnostics, Inc. | 1989-02-24 |
| HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS (K854236) | Nms Pharmaceuticals, Inc. | 1986-10-10 |
| CAMCO STAIN PAK (K860793) | Cambridge Chemical Products, Inc. | 1986-03-18 |
| HEMATOLOGY STAIN PACK (K853241) | Fisher Scientific Co., LLC | 1985-08-19 |
| WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S (K852138) | Canyon Diagnostics, Inc. | 1985-06-13 |
| WRIGHT STAIN (K842744) | E K Ind., Inc. | 1984-08-12 |
| HEMATOLOGY WRIGHT'S STAIN PACK (K833678) | J.S. Medical Assoc. | 1983-11-25 |
| STAIN PACK FOR AEROSPRAY SLIDE STAINER (K833260) | Wescor, Inc. | 1983-10-28 |
| HEMATOLOGY PAK (K831605) | Mercedes Scientific Co., Inc. | 1983-06-30 |
| HEMAQUIK II STAINING SOLUTION #55961 (K830542) | Accra Laboratories, Inc. | 1983-03-17 |
| QUIK-DIP BLOOD STAIN (K830127) | Mercedes Scientific Co., Inc. | 1983-02-15 |
Recalls involving this device
No recalls on record reference this clearance.