Gem Premier Plus Model 5500
FDA 510(k) K961335 · Mallinckrodt Sensor Systems, Inc.
510(k) numberK961335
Submission
- Device name
- Gem Premier Plus Model 5500
- Applicant
- Mallinckrodt Sensor Systems, Inc.
Ann Arbor, MI, US - Received
- April 8, 1996
- Decision date
- June 28, 1996
- 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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|---|---|---|---|
| K252207 | ABL90 FLEX PLUS System, safeCLINITUBESCHL · Traditional | Radiometer Medicals Aps | 04/10/2026SE |
| K244014 | i-STAT CG4+ cartridge with the i-STAT 1 SystemCHL · Traditional | Abbott Point of Care, Inc. | 05/02/2025SE |
| K240998 | ABL90 FLEX PLUS SystemCHL · Traditional | Radiometer Medicals Aps | 12/13/2024SE |
| 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 |
| K203790 | GEM Premier 5000CHL · Special | Instrumentation Laboratory CO | 08/20/2021SE |
| K200986 | OPTI® B-Lac CassetteCHL · Traditional | Opti Medical Systems, Inc. | 08/02/2021SE |
More from Opti Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K910305 | Gem-Premier SystemJGS · Traditional | 04/03/1991SE |
Questions and answers
When was Gem Premier Plus Model 5500 cleared by the FDA?
Gem Premier Plus Model 5500 (K961335) received a 510(k) decision of Substantially Equivalent on June 28, 1996, 81 days after the submission was received.
What is the product code of K961335?
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.