510(k) K770830
- Device
- PLATELET AGITATOR
- Applicant
- Helmer Labs, Inc.
- 510(k) number
- K770830
- Product code
- GLE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-07-11
- Date received
- 1977-05-06
- Regulation
- 862.2050
- Classification name
- Mixer, Blood Tube
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3007123908
- 3034669683
- 3010960914
- 3007006186
- 3009711478
- 3009155756
- 3013530901
- 3043009938
- 2244900
- 3010148979
- 3003799895
- 2249760
- 3006697110
- 9617475
- 9613959
- 3021639773
- 2242368
- 3016758972
- 3017299606
- 3020704087
- 3015946784
- 3008496560
- 3031184338
- 3010194621
- 1064584
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GLE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K823124 | IMS HEMATOLOGY MIXER | Innovative Medical Systems, Inc. | 1982-11-22 |
| K800003 | CORTEX DOUBLE HELIX SAMPLER | Cortex Research Corp. | 1980-02-01 |
| K780544 | DISC-PAK ROTATOR | Techhnilab Instruments, Inc. | 1978-04-24 |
| K771617 | SPECI-MIX | Thermolyne Corp. | 1977-09-02 |