CSM Chromogenic B-Lactamase Disc
FDA 510(k) K822930 · Carr-Scarborough Microbiologicals, Inc.
510(k) numberK822930
Submission
- Device name
- CSM Chromogenic B-Lactamase Disc
- Applicant
- Carr-Scarborough Microbiologicals, Inc.
Mchenry, IL, US - Received
- October 4, 1982
- Decision date
- November 1, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTO – Discs, Strips And Reagents, Microorganism Differentiation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
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| K863216 | Neis NzyJTO · Traditional | 09/15/1986SE |
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Questions and answers
When was CSM Chromogenic B-Lactamase Disc cleared by the FDA?
CSM Chromogenic B-Lactamase Disc (K822930) received a 510(k) decision of Substantially Equivalent on November 1, 1982, 28 days after the submission was received.
What is the product code of K822930?
The FDA product code is JTO – Discs, Strips And Reagents, Microorganism Differentiation, a Class I (low risk) device regulated under 21 CFR 866.2660.