Spinalscopics
FDA 510(k) K970862 · Quantimetrix Corp.
510(k) numberK970862
Submission
- Device name
- Spinalscopics
- Applicant
- Quantimetrix Corp.
Redondo Beach, CA, US - Received
- March 7, 1997
- Decision date
- April 8, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K143379 | Liquichek Maternal Serum II ControlJJY · Traditional | Bio-Rad Laboratories | 03/13/2015SE |
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| K142978 | Audit MicroControls Linearity LQ Special DiabetesJJY · Traditional | Aalto Scientific, Ltd. | 11/20/2014SE |
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| K062942 | Quantimetrix Nicosure Cotinine Urine ControlLAS · Traditional | 10/30/2006SE |
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| K032791 | Glycohemosure HBA1C ControlGGM · Traditional | 10/30/2003SE |
| K030826 | Preciset Dat AmphetamineDIJ · Traditional | 04/03/2003SE |
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Questions and answers
When was Spinalscopics cleared by the FDA?
Spinalscopics (K970862) received a 510(k) decision of Substantially Equivalent on April 8, 1997, 32 days after the submission was received.
What is the product code of K970862?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.