Hypronosticon TM
FDA 510(k) K770603 · Organon, Inc.
510(k) numberK770603
Submission
- Device name
- Hypronosticon TM
- Applicant
- Organon, Inc.
Mchenry, IL, US - Received
- March 30, 1977
- Decision date
- September 2, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K011052 | Osteomark NTX Point of Care Prescription Home UseJMM · Traditional | Ostex Intl., Inc. | 07/30/2001SE |
| K993706 | Elecsys Serum B-Crosslaps/Serum ImmunoassayJMM · Traditional | Roche Diagnostics Corp. | 07/24/2000SE |
| K992997 | Osteomark NTX PocJMM · Traditional | Metrika, Inc. | 11/09/1999SE |
| K990843 | Serum Crosslaps One Step ElisaJMM · Traditional | Osteometer Biotech A/S | 07/09/1999SE |
| K983457 | Osteomark NTX Serum EiaJMM · Traditional | Ostex Intl., Inc. | 02/02/1999SE |
| K983674 | Vitros Immunodiagnostic Products: NTX Calibrators, NTX Reagent Pack, NTX ControlsJMM · Traditional | Ortho-Clinical Diagnostics, Inc. | 01/29/1999SE |
| K972788 | Crosslaps ElisaJMM · Traditional | Devices and Diagnostics Consulting Group | 12/22/1998SE |
| K981364 | Pyrilinks-D Assay KitJMM · Traditional | Metra Biosystems, Inc. | 08/13/1998SE |
| K980833 | Immulite Pyrilinks-D Model Numbers LKPD1, LKPD5JMM · Traditional | Diagnostic Products Corp. | 05/01/1998SE |
| K980518 | OsteomarkJMM · Traditional | Ostex Intl., Inc. | 03/06/1998SE |
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| K853388 | Monosticon Uni-DotKTN · Traditional | 08/22/1985SE |
| K842314 | Duoclon Color-CeptJHJ · Traditional | 08/24/1984SE |
| K841525 | Oreia II B-Hcg Pregnancy Test KitJHI · Traditional | 06/05/1984SE |
| K841602 | Accurate Beta 30 Pregnancy Test KitLCX · Traditional | 05/22/1984SE |
| K840650 | B-Neocept 30JHJ · Traditional | 04/04/1984SE |
| K832801 | Oreia II B-Hcg, Enzyme InnunoassayJHI · Traditional | 12/08/1983SE |
| K831339 | Neo-Pregnosticon Duoclon Tube TestJHJ · Traditional | 06/08/1983SE |
| K831109 | Duoclon Slide TestJHI · Traditional | 06/02/1983SE |
Questions and answers
When was Hypronosticon TM cleared by the FDA?
Hypronosticon TM (K770603) received a 510(k) decision of Substantially Equivalent on September 2, 1977, 156 days after the submission was received.
What is the product code of K770603?
The FDA product code is JMM – Column Chromatography & Color Development, Hydroxyproline, a Class I (low risk) device regulated under 21 CFR 862.1400.