FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BI PLATE-XLD/HEKTOEN #30012
K Number: K821108
·
Decision May 13, 1982
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
284
Applicant Total
19
Review Days
23
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Basic Information
- Device Name
- BI PLATE-XLD/HEKTOEN #30012
- K Number
- K821108
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Biomedia, Inc.
- Date Received
- April 20, 1982
- Decision Date
- May 13, 1982
- Product Code
- JSI
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JSI | Culture Media, Selective And Differential | FDA class 1 | Microbiology |
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Other Clearances by Biomedia, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K821300 | #2010 CAMPHYLOBACTER AGAR | Jun 2, 1982 | Substantially Equivalent |
| K821301 | #50002 QUAD DIAGNOSTIC SYSTEM | Jun 1, 1982 | Substantially Equivalent |
| K821302 | #50003 QUAD DIAGNOSTIC SYSTEM | Jun 1, 1982 | Substantially Equivalent |
| K811478 | EMB AGAR, LEVINE | Jun 18, 1981 | Substantially Equivalent |
| K811479 | CHODOLATE AGAR, ENRICHED | Jun 18, 1981 | Substantially Equivalent |
| K811476 | THAYER MARTIN AGAR | Jun 18, 1981 | Substantially Equivalent |
| K811471 | MUELLER HINTON AGAR | Jun 18, 1981 | Substantially Equivalent |
| K811475 | TRYPTIC SOY AGAR W/5% & 10% SHEEP BLOOD | Jun 18, 1981 | Substantially Equivalent |
| K811473 | MUELLER HINTON AGAR W/5% SHEEP BLOOD | Jun 18, 1981 | Substantially Equivalent |
| K811472 | MUELLER HINTON AGAR, POURED INTO A PLATE | Jun 18, 1981 | Substantially Equivalent |