AFRICAN GREEN MONKEY BLOOD IN ALSERVERS
FDA 510(k) clearance K813513 · decided 1981-12-31
Clearance details
- K-number
- K813513
- Device name
- AFRICAN GREEN MONKEY BLOOD IN ALSERVERS
- Applicant
- Dutchland Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-12-15
- Decision date
- 1981-12-31
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- LHW
- Device class
- 1
- Regulation number
- 866.3720
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- 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 |
|---|---|---|
| BLUE RIDGE RABBIT BLOOD (K820849) | Blue Ridge Media Co. | 1982-04-16 |
| BLUE RIDGE SHEEP BLOOD (K820848) | Blue Ridge Media Co. | 1982-04-16 |
| RHESUS MONKEY BLOOD IN ALSEVER'S (K813512) | Dutchland Laboratories, Inc. | 1981-12-29 |
Recalls involving this device
No recalls on record reference this clearance.