ULTRAFREE CALCIUM FILTER
FDA 510(k) clearance K801500 · decided 1980-08-20
Clearance details
- K-number
- K801500
- Device name
- ULTRAFREE CALCIUM FILTER
- Applicant
- Millipore Corp.
- Decision
- Substantially Equivalent
- Date received
- 1980-06-27
- Decision date
- 1980-08-20
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- JRL
- Device class
- 1
- Regulation number
- 862.2050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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 |
|---|---|---|
| ACRO PACK (K822121) | Gelman Sciences, Inc. | 1982-08-05 |
| CENTRIFREE MICROPARTITION SYSTEM (K820455) | Amicon, Inc. | 1982-03-15 |
| EMIT FREELEVEL SYSTEM I (K820224) | Syva Co. | 1982-02-23 |
| IL 703, STAT SEPARATOR (K812750) | Instrumentation Laboratory CO | 1982-01-26 |
| VACUSHIELD TM (K813159) | Gelman Sciences, Inc. | 1981-12-08 |
| ACRODISC (K810829) | Gelman Sciences, Inc. | 1981-04-08 |
| ULTRA-FREE (K790445) | Millipore Corp. | 1979-06-28 |
| CEA-IMMERSIBLE SEPARATOR (K781043) | Millipore Corp. | 1978-09-15 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| THERAPEUTIC APHERESIS SYSTEM (P850092) | Millipore Corp. | 1986-11-18 |