510(k) K964052
- Device
- HEMOCUE HEMOTROL
- Applicant
- DIRECT SOLUTIONS
- 510(k) number
- K964052
- Product code
- GGM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-11-06
- Date received
- 1996-09-30
- Regulation
- 864.8625
- Classification name
- Control, Hemoglobin
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BILL DONOHUE
- Address
- 7 Hayrick Ln. P.O. Box 900 Westford MA US 01886 01886
FDA Registration Numbers#
- 2244821
- 3014150341
- 3004838836
- 2016706
- 9615507
- 3002821232
- 9681518
- 1649661
- 3004493545
- 2182501
- 3010891909
- 3009491259
- 9610806
- 2531491
- 2032112
- 3010127294
- 3005333358
- 1616487
Source Documents#
Other 510(k) Records For Product Code GGM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192842 | HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High | Eurotrol B.V. | 2019-11-15 |
| K182744 | HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High | Eurotrol B.V. | 2019-02-01 |
| K070546 | LYPHOCHEK DIABETES CONTROL | Bio-Rad Laboratories | 2007-04-02 |
| K070334 | R&D SICKLE QC CONTROL | R&D Systems, Inc. | 2007-03-29 |
| K052838 | LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 | Bio-Rad | 2005-11-09 |
| K032791 | GLYCOHEMOSURE HBA1C CONTROL | Quantimetrix Corp. | 2003-10-30 |
| K003030 | LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET | Bio-Rad | 2000-11-29 |
| K993321 | R&D HGB/GLC WHOLE BLOOD CONTROL | R&D Systems, Inc. | 1999-11-12 |
| K963908 | HEMOCUE HEMOLIN | Direct Solutions | 1996-10-16 |
| K921681 | CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL | Isolab, Inc. | 1992-11-17 |
| K893985 | HGB-CONTROL SET/MULTIPLE | R&D Systems, Inc. | 1989-08-15 |
| K852136 | PRECINORM HB | Boehringer Mannheim Corp. | 1985-07-05 |
| K800296 | WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 | Dade, Baxter Travenol Diagnostics, Inc. | 1980-03-05 |
| K790310 | HEMOGLOBIN CONTROLS | Electrophoresis Corp. | 1979-03-21 |
Legacy Summary#
summary
FDA Review#
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