FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
#50003 QUAD DIAGNOSTIC SYSTEM
K Number: K821302
·
Decision Jun 1, 1982
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
145
Applicant Total
19
Review Days
28
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Basic Information
- Device Name
- #50003 QUAD DIAGNOSTIC SYSTEM
- K Number
- K821302
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Biomedia, Inc.
- Date Received
- May 4, 1982
- Decision Date
- June 1, 1982
- Product Code
- JSH
- 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 |
|---|---|---|---|
| JSH | Culture Media, Non-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 |
| K821108 | BI PLATE-XLD/HEKTOEN #30012 | May 13, 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 |