Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with Co-Ox; Gem CVP 3 and 4 Hematocrit
FDA 510(k) K061974 · Instrumentation Laboratory CO
510(k) numberK061974
Submission
- Device name
- Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with Co-Ox; Gem CVP 3 and 4 Hematocrit
- Applicant
- Instrumentation Laboratory CO
Bedford, MA, US - Received
- July 12, 2006
- Decision date
- September 15, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1120
- Specialty
- Clinical Chemistry
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| K230285 | i-STAT CG8+ cartridge with the i-STAT 1 SystemCHL · Traditional | Abbott Point of Care, Inc. | 10/27/2023SE |
| K221900 | Stat Profile Prime Plus Analyzer SystemCHL · Traditional | Nova Biomedical Corporation | 09/29/2023SE |
| K223857 | i-STAT G3+ cartridge with the i-STAT 1 SystemCHL · Traditional | Abbott Point of Care, Inc. | 09/15/2023SE |
| K223608 | GEM Premier 7000 with IQM3CHL · Traditional | Instrumentation Laboratory Company | 08/10/2023SE |
| K211559 | EasyStat 300CHL · Traditional | Medica Corporation | 01/27/2023SE |
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| K200986 | OPTI® B-Lac CassetteCHL · Traditional | Opti Medical Systems, Inc. | 08/02/2021SE |
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| K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMJPA · Traditional | 09/29/2023SE |
| K223608 | GEM Premier 7000 with IQM3CHL · Traditional | 08/10/2023SE |
| K223187 | HemosIL Liquid Anti-XaQLU · Traditional | 06/23/2023SE |
| K231031 | ACL TOP Family 70 SeriesGKP · Traditional | 06/21/2023SE |
| K223090 | GEM Premier ChemSTATCGA · Special | 01/27/2023SE |
| K223402 | HemosIL von Willebrand Factor AntigenGGP · Special | 12/09/2022SE |
| K213464 | HemosIL Liquid Anti-XaKFF · Special | 10/04/2022SE |
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Questions and answers
When was Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with Co-Ox; Gem CVP 3 and 4 Hematocrit cleared by the FDA?
Gem Premier 4000 with Iqm, Model 4000; Gem CVP 1 and 2 with Co-Ox; Gem CVP 3 and 4 Hematocrit (K061974) received a 510(k) decision of Substantially Equivalent on September 15, 2006, 65 days after the submission was received.
What is the product code of K061974?
The FDA product code is CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, a Class II (moderate risk) device regulated under 21 CFR 862.1120.