HEMATOLOGY QUALITY CONTROL MIXTURE
FDA 510(k) clearance K823930 · decided 1983-02-01
Clearance details
- K-number
- K823930
- Device name
- HEMATOLOGY QUALITY CONTROL MIXTURE
- Applicant
- Fisher Scientific Co., LLC
- Decision
- Substantially Equivalent
- Date received
- 1982-12-29
- Decision date
- 1983-02-01
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- GJP
- Device class
- 2
- Regulation number
- 864.8625
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Fisher Scientific Co.
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 |
|---|---|---|
| MSI-PC (K880608) | Medical Specialties, Inc. | 1988-03-21 |
| PLATELET CONTROLS NORMAL & ABNORMAL (K771588) | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-25 |
| LATELET DETERMIBATION KIT, UL 800 (K770655) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-06-24 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| FLUORESCENT GONORRHEA TEST-HEATED (FGT-H) (P770001) | Fisher Scientific Co., LLC | 1979-07-18 |