510(k) K972861
- Device
- IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3)
- Applicant
- INSTRUMENTATION LABORATORY CO.
- 510(k) number
- K972861
- Product code
- JJS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-08-19
- Date received
- 1997-08-04
- Regulation
- 862.1660
- Classification name
- Controls For Blood-gases, (assayed And Unassayed)
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BETTY J LANE
- Address
- 113 Hartwell Ave. Lexington MA US 02173 02173
FDA Registration Numbers#
- 3006198300
- 9681518
- 3003030793
- 3005333358
- 2432235
- 3011325031
- 3003971136
- 1827821
- 3002637618
- 9610746
- 3004493545
- 3002807968
- 2016706
- 1222035
- 3013513377
- 1220649
- 3023162659
- 1219029
- 3010127294
Source Documents#
Other 510(k) Records For Product Code JJS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K152553 | CueSee Hypoxic | Eurotrol B.V. | 2016-04-22 |
| K150226 | Hematocrit and Metabolite QUALICHECK | Radiometer Medical Aps | 2015-05-13 |
| K130415 | HIGH METABOLITE QUALICHECK | Radiometer Medical Aps | 2013-03-26 |
| K130236 | RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 | Radiometer Medical Aps | 2013-03-15 |
| K033063 | MISSION CONTROLS | Diamond Diagnostics, Inc. | 2003-12-12 |
| K022525 | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509 | Bio-Rad | 2002-08-15 |
| K022529 | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669 | Bio-Rad | 2002-08-15 |
| K003239 | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506 | Bio-Rad | 2000-11-30 |
| K003242 | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623 | Bio-Rad | 2000-11-30 |
| K002865 | LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 | Bio-Rad | 2000-09-25 |
| K002866 | LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574 | Bio-Rad | 2000-09-25 |
| K002535 | LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513 | Bio-Rad | 2000-08-30 |
| K002536 | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER) | Bio-Rad | 2000-08-30 |
| K002120 | LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573 | Bio-Rad | 2000-08-21 |
| K980135 | QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 | Radiometer America, Inc. | 1998-01-28 |
Legacy Summary#
summary
FDA Review#
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