Pentex Lipoprotein Cholesterol Solu.
FDA 510(k) K800035 · Miles Laboratories, Inc.
510(k) numberK800035
Submission
- Device name
- Pentex Lipoprotein Cholesterol Solu.
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- January 7, 1980
- Decision date
- January 21, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Pentex Lipoprotein Cholesterol Solu. cleared by the FDA?
Pentex Lipoprotein Cholesterol Solu. (K800035) received a 510(k) decision of Substantially Equivalent on January 21, 1980, 14 days after the submission was received.
What is the product code of K800035?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.