MMB Calibrator
FDA 510(k) K970336 · Dade Chemistry Systems, Inc.
510(k) numberK970336
Submission
- Device name
- MMB Calibrator
- Applicant
- Dade Chemistry Systems, Inc.
Newark, DE, US - Received
- January 29, 1997
- Decision date
- March 3, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K973650 | Troponin (Trop) MethodMMI · Traditional | 10/20/1997SE |
| K973100 | Prostate Specific Antigen (Psa) CalibratorJIT · Traditional | 09/29/1997SE |
| K973099 | Prostate Specific Antigen ControlJJX · Traditional | 09/29/1997SE |
| K973101 | Prostate Specific Antigen MethodLTJ · Traditional | 09/18/1997SE |
| K971141 | FT4 Method for the Dimension RXL Clinical Chemistry SystemCEC · Traditional | 04/28/1997SE |
| K970387 | Human Chorionic Gonadotropin MethodDHA · Traditional | 03/10/1997SE |
| K970393 | Thyroid Stimulating Hormone MethodJLW · Traditional | 03/03/1997SE |
| K970396 | Human Chorionic Gonadotropin CalibratorJIW · Traditional | 02/20/1997SE |
| K970389 | Thyroid CalibratorJIT · Traditional | 02/18/1997SE |
| K970343 | MMB MethodJHY · Traditional | 02/14/1997SE |
Questions and answers
When was MMB Calibrator cleared by the FDA?
MMB Calibrator (K970336) received a 510(k) decision of Substantially Equivalent on March 3, 1997, 33 days after the submission was received.
What is the product code of K970336?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.