HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE
FDA 510(k) clearance K811011 · decided 1981-05-15
Clearance details
- K-number
- K811011
- Device name
- HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE
- Applicant
- Sigma Chemical Co.
- Decision
- Substantially Equivalent
- Date received
- 1981-04-15
- Decision date
- 1981-05-15
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- GIA
- Device class
- 1
- Regulation number
- 864.7675
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sigma Chemical 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 |
|---|---|---|
| FAST'N'FLAMMATORY KIT (K931241) | Techlab, Inc. | 1994-02-03 |
| SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR (K844402) | Sigma Chemical Co. | 1985-01-04 |
Recalls involving this device
No recalls on record reference this clearance.