Reader, Zone, Automated
The Automated Zone Reader is a microbiology instrument that uses optical sensing or image analysis to automatically interpret and record antimicrobial susceptibility test results by measuring inhibition zones around antibiotic discs on culture plates, reducing the variability of manual reading. It is classified as FDA Class 1, the lowest risk category, and requires a 510(k) premarket notification before marketing based on its assigned submission type. The product code is KZK, regulated under 21 CFR 866.2850, in the Microbiology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- KZK
- Device Class
- FDA class 1
- Regulation Number
- 866.2850
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K991473 | SIRSCAN | Nov 23, 1999 | Substantially Equivalent | Intelligence Artificielle Applications |
| K944319 | BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM | Dec 15, 1994 | Substantially Equivalent | Giles Scientific, Inc. |
| K932122 | BIOMIC VIDEO PLATE READER | Mar 01, 1994 | Substantially Equivalent | Giles Scientific, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.