Alt Incorporating DST
FDA 510(k) K961123 · Trace Scientific , Ltd.
510(k) numberK961123
Submission
- Device name
- Alt Incorporating DST
- Applicant
- Trace Scientific , Ltd.
Miami, FL, US - Received
- March 21, 1996
- Decision date
- April 25, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1030
- Specialty
- Clinical Chemistry
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| K971323 | Alt or SGPTCKA · Traditional | Carolina Liquid Chemistries Corp. | 04/21/1997SE |
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More from Beckman Instruments, Inc.
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| K962890 | Cholesterol-Incorporating Dynamic Stab Tech (DST)CHH · Traditional | 09/27/1996SE |
| K961114 | Ast Incorporating DSTCIT · Traditional | 05/23/1996SE |
| K952488 | Trace Cobas Mira RangeCIX · Traditional | 10/13/1995SE |
| K932713 | Trace Transferrin ReagentDDQ · Traditional | 09/30/1993SE |
| K923322 | Trace Albumin-Mr ReagentCIX · Traditional | 09/11/1992SE |
| K914731 | Trace Gamma Gt-Ss ReagentJQB · Traditional | 11/19/1991SE |
| K911866 | Trace Total/Direct Bilirubin ReagentCIG · Traditional | 07/17/1991SE |
| K903897 | Triglycerides Reagent Gpo 5 X Conc.CDT · Traditional | 10/01/1990SE |
Questions and answers
When was Alt Incorporating DST cleared by the FDA?
Alt Incorporating DST (K961123) received a 510(k) decision of Substantially Equivalent on April 25, 1996, 35 days after the submission was received.
What is the product code of K961123?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.