Deoxypyridinoline Assay for the Bayer Immuno 1 System
FDA 510(k) K972580 · Bayer Corp.
510(k) numberK972580
Submission
- Device name
- Deoxypyridinoline Assay for the Bayer Immuno 1 System
- Applicant
- Bayer Corp.
Tarrytown, NY, US - Received
- July 10, 1997
- Decision date
- September 22, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JMM – Column Chromatography & Color Development, Hydroxyproline
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1400
- Specialty
- Clinical Chemistry
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| K972788 | Crosslaps ElisaJMM · Traditional | Devices and Diagnostics Consulting Group | 12/22/1998SE |
| K981364 | Pyrilinks-D Assay KitJMM · Traditional | Metra Biosystems, Inc. | 08/13/1998SE |
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| K980518 | OsteomarkJMM · Traditional | Ostex Intl., Inc. | 03/06/1998SE |
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Questions and answers
When was Deoxypyridinoline Assay for the Bayer Immuno 1 System cleared by the FDA?
Deoxypyridinoline Assay for the Bayer Immuno 1 System (K972580) received a 510(k) decision of Substantially Equivalent on September 22, 1997, 74 days after the submission was received.
What is the product code of K972580?
The FDA product code is JMM – Column Chromatography & Color Development, Hydroxyproline, a Class I (low risk) device regulated under 21 CFR 862.1400.