STAT STAIN SET
FDA 510(k) clearance K810495 · decided 1981-03-17
Clearance details
- K-number
- K810495
- Device name
- STAT STAIN SET
- Applicant
- Accra Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-02-24
- Decision date
- 1981-03-17
- Days to decision
- 21 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
+ Add to Predicate Builder ◉ Watch Accra Laboratories
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 |
|---|---|---|
| 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 |
| WRIGHT-GIEMSA QUICK STAIN (K842745) | E K Ind., Inc. | 1984-08-10 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.