Reagent Set, SGPT Serum Glutamic
FDA 510(k) K781726 · Medical Analysis Systems, Inc.
510(k) numberK781726
Submission
- Device name
- Reagent Set, SGPT Serum Glutamic
- Applicant
- Medical Analysis Systems, Inc.
Mchenry, IL, US - Received
- October 11, 1978
- Decision date
- November 3, 1978
- 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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Questions and answers
When was Reagent Set, SGPT Serum Glutamic cleared by the FDA?
Reagent Set, SGPT Serum Glutamic (K781726) received a 510(k) decision of Substantially Equivalent on November 3, 1978, 23 days after the submission was received.
What is the product code of K781726?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.