Km-Kal L6
FDA 510(k) K823023 · Kmn Products, Inc.
510(k) numberK823023
Submission
- Device name
- Km-Kal L6
- Applicant
- Kmn Products, Inc.
Mchenry, IL, US - Received
- October 13, 1982
- Decision date
- November 16, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIT – Calibrator, Secondary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K171168 | VITROS Immunodiagnostic Products Insulin CalibratorsJIT · Abbreviated | Ortho Clinical Diagnostics | 05/16/2017SE |
| K170938 | CalSet IGF-1JIT · Traditional | Roche Diagnostics | 04/26/2017SE |
| K170160 | Abbott ARCHITECT Free T3JIT · Traditional | Abbott Laboratories | 02/15/2017SE |
| K163546 | Lumipulse G Progesterone-N CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/13/2017SE |
| K163534 | Lumipulse G FSH-N CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/13/2017SE |
| K163544 | Lumipulse G ProlactinJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/12/2017SE |
| K163521 | Lumipulse G LH CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/12/2017SE |
| K163078 | Dc-Uibc-CalJIT · Abbreviated | Sekisui Diagnostics P.E.I., Inc. | 12/08/2016SE |
| K163053 | Lumipulse G E2-III CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 12/01/2016SE |
| K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorJIT · Special | Siemens Healthcare Diagnostics | 11/17/2016SE |
More from Siemens Healthcare Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K823044 | Km-Kal L3JIX · Traditional | 12/09/1982SE |
| K823025 | KM - Kal 2JIT · Traditional | 11/16/1982SE |
| K823024 | KM - Kal 1JIT · Traditional | 11/16/1982SE |
| K823022 | Km-Kal 6JIT · Traditional | 11/16/1982SE |
| K823021 | KM - Kal 5JIT · Traditional | 11/16/1982SE |
| K823020 | Km-Kal 4JIT · Traditional | 11/16/1982SE |
| K823019 | Km-Kal 3JIT · Traditional | 11/16/1982SE |
| K823046 | Km-Kal L5JIX · Traditional | 11/05/1982SE |
| K823045 | Km-Kal L4JIX · Traditional | 11/05/1982SE |
| K823043 | Km-Kal L2JIX · Traditional | 11/05/1982SE |
Questions and answers
When was Km-Kal L6 cleared by the FDA?
Km-Kal L6 (K823023) received a 510(k) decision of Substantially Equivalent on November 16, 1982, 34 days after the submission was received.
What is the product code of K823023?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.