Clinistat SGPT (Alt) Serum Glutamate Pyruvate Tran
FDA 510(k) K885144 · Heraeus Kulzer, Inc.
510(k) numberK885144
Submission
- Device name
- Clinistat SGPT (Alt) Serum Glutamate Pyruvate Tran
- Applicant
- Heraeus Kulzer, Inc.
Elkhart, IN, US - Received
- December 15, 1988
- Decision date
- February 2, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K961123 | Alt Incorporating DSTCKA · Traditional | Trace Scientific , Ltd. | 04/25/1996SE |
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Questions and answers
When was Clinistat SGPT (Alt) Serum Glutamate Pyruvate Tran cleared by the FDA?
Clinistat SGPT (Alt) Serum Glutamate Pyruvate Tran (K885144) received a 510(k) decision of Substantially Equivalent on February 2, 1989, 49 days after the submission was received.
What is the product code of K885144?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.