Kodak Ektachem DT Slides (Lac)
FDA 510(k) K913197 · Eastman Kodak Company
510(k) numberK913197
Submission
- Device name
- Kodak Ektachem DT Slides (Lac)
- Applicant
- Eastman Kodak Company
Rochester, NY, US - Received
- July 18, 1991
- Decision date
- August 26, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Kodak Ektachem DT Slides (Lac) cleared by the FDA?
Kodak Ektachem DT Slides (Lac) (K913197) received a 510(k) decision of Substantially Equivalent on August 26, 1991, 39 days after the submission was received.
What is the product code of K913197?
The FDA product code is KHP – Acid, Lactic, Enzymatic Method, a Class I (low risk) device regulated under 21 CFR 862.1450.