510(k) K812892
- Device
- S/p Serum Dropper Pipets
- Applicant
- AMERICAN DADE
- 510(k) number
- K812892
- Product code
- KSS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-10-27
- Date received
- 1981-10-15
- Regulation
- 864.9050
- Classification name
- Supplies, Blood-Bank
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Related Records
Applicant Contact
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers
- 3005951296
- 1722028
- 3004634229
- 3010359414
- 3010220595
- 1019003
- 3004437723
- 1450662
- 3005720829
- 3004548776
- 2530788
- 1317202
- 3009404601
- 3014345398
- 1424263
- 3011683976
- 3005778453
- 1417592
- 3023339256
- 9612051
- 9710488
- 3003895930
- 1825034
- 3037389071
- 2247045
- 1424489
- 3010047203
- 1034569
- 1226544
- 3004404323
- 3012082309
- 3008246752
- 9681839
- 3012239588
- 3008810357
- 9681633
- 2080225
- 8010026
- 1056600
- 3010376880
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KSS
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K874436 | FLUID SAMPLING PACK | U.S. Mfg. & Management, Inc. | 1988-01-05 |
| K801386 | PRE-DENT SYSTEM OR PRE-DENT II | Pre-Dent System | 1980-07-14 |
| K801516 | PRE-DENT SYSTEM MODIFIED | Pre-Dent System | 1980-07-14 |
| K800736 | PRE-DENT SYSTEM | Pre-Dent System | 1980-04-24 |
| K761303 | IMMU-SAL IMMUNOHEMATOLOGICAL SALINE | Dade, Baxter Travenol Diagnostics, Inc. | 1976-12-30 |