510(k) K820224
- Device
- Emit Freelevel System I
- Applicant
- SYVA CO.
- 510(k) number
- K820224
- Product code
- JRL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-02-23
- Date received
- 1982-01-27
- Regulation
- 862.2050
- Classification name
- Unit, Filter, Membrane
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1721676
- 3015505238
- 3004594181
- 8020892
- 3013557562
- 1055236
- 3017886332
- 1825146
- 3038200636
- 3006061749
- 3013000203
- 1064005
- 3011966385
- 3019027610
- 8021995
- 3027645317
- 3010834934
- 3010132111
- 9612003
- 3010187802
- 1836161
- 3002807315
- 1036836
- 3008958625
- 3015309643
- 3014810929
- 3021244152
- 3011716786
- 3015134079
- 3013152643
- 2029275
- 3019387954
- 3009893608
- 3004612223
- 3012536737
- 1043214
- 3042175944
- 3037025992
- 1820334
- 1054811
- 3036979319
- 1066491
- 3014236293
- 1724474
- 3033589330
- 3006563173
- 3006446479
- 8030607
- 2028411
- 3003485902
- 3044563261
- 3015225571
- 3010420046
- 1054241
- 1721504
- 3006950086
- 3016195240
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JRL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K822121 | ACRO PACK | Gelman Sciences, Inc. | 1982-08-05 |
| K820455 | CENTRIFREE MICROPARTITION SYSTEM | Amicon, Inc. | 1982-03-15 |
| K812750 | IL 703, STAT SEPARATOR | Instrumentation Laboratory CO | 1982-01-26 |
| K813159 | VACUSHIELD TM | Gelman Sciences, Inc. | 1981-12-08 |
| K810829 | ACRODISC | Gelman Sciences, Inc. | 1981-04-08 |
| K801500 | ULTRAFREE CALCIUM FILTER | Millipore Corp. | 1980-08-20 |
| K790445 | ULTRA-FREE | Millipore Corp. | 1979-06-28 |
| K781043 | CEA-IMMERSIBLE SEPARATOR | Millipore Corp. | 1978-09-15 |