La-Sporo Antibody System
FDA 510(k) K802427 · Immuno-Mycologics, Inc.
510(k) numberK802427
Submission
- Device name
- La-Sporo Antibody System
- Applicant
- Immuno-Mycologics, Inc.
Mchenry, IL, US - Received
- October 6, 1980
- Decision date
- October 31, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GMA – Antisera, Fluorescent, Sporothrix Schenekii
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3680
- Specialty
- Microbiology
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Questions and answers
When was La-Sporo Antibody System cleared by the FDA?
La-Sporo Antibody System (K802427) received a 510(k) decision of Substantially Equivalent on October 31, 1980, 25 days after the submission was received.
What is the product code of K802427?
The FDA product code is GMA – Antisera, Fluorescent, Sporothrix Schenekii, a Class I (low risk) device regulated under 21 CFR 866.3680.