MYCOPLASMA ARGININI FITC (30-403-41)
FDA 510(k) clearance K781874 · decided 1978-12-20
Clearance details
- K-number
- K781874
- Device name
- MYCOPLASMA ARGININI FITC (30-403-41)
- Applicant
- Flow Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-11-03
- Decision date
- 1978-12-20
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- KPB
- Device class
- 1
- Regulation number
- 864.2360
- 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 |
|---|---|---|
| STAIN KIT FOR CELL CULTURES (30-100-00) (K781875) | Flow Laboratories, Inc. | 1978-12-20 |
| MYCOPLASMA HYORHINIS (BTS-7) (K781390) | Flow Laboratories, Inc. | 1978-09-01 |
| MYCOPLASMA DETECTION KIT (K771867) | Bioassay Systems Research Corp. | 1977-11-17 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 3M BRAND MICROBIAL PROFILE SYSTEM (N50538/S001) | Flow Laboratories, Inc. | 1981-04-17 |
| FLOW MIC SYSTEM (N50538) | Flow Laboratories, Inc. | 1980-07-15 |