Dimension(R) Lactic Acid Method
FDA 510(k) K914508 · E.I. Dupont DE Nemours & Co., Inc.
510(k) numberK914508
Submission
- Device name
- Dimension(R) Lactic Acid Method
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
Wilmington, DE, US - Received
- October 9, 1991
- Decision date
- November 27, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KHP – Acid, Lactic, Enzymatic Method
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1450
- Specialty
- Clinical Chemistry
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Questions and answers
When was Dimension(R) Lactic Acid Method cleared by the FDA?
Dimension(R) Lactic Acid Method (K914508) received a 510(k) decision of Substantially Equivalent on November 27, 1991, 49 days after the submission was received.
What is the product code of K914508?
The FDA product code is KHP – Acid, Lactic, Enzymatic Method, a Class I (low risk) device regulated under 21 CFR 862.1450.