Zithromax
FDA 510(k) K922792 · Difco Laboratories, Inc.
510(k) numberK922792
Submission
- Device name
- Zithromax
- Applicant
- Difco Laboratories, Inc.
Detroit, MI, US - Received
- June 9, 1992
- Decision date
- July 30, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JNT – Chromatographic, Phospholipids
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1575
- Specialty
- Clinical Chemistry
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Questions and answers
When was Zithromax cleared by the FDA?
Zithromax (K922792) received a 510(k) decision of Substantially Equivalent on July 30, 1992, 51 days after the submission was received.
What is the product code of K922792?
The FDA product code is JNT – Chromatographic, Phospholipids, a Class I (low risk) device regulated under 21 CFR 862.1575.