FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SABOURAND DEXTROSE AGAR
K Number: K830066
·
Decision Feb 9, 1983
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
306
Applicant Total
251
Review Days
29
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SABOURAND DEXTROSE AGAR
- K Number
- K830066
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- bioMerieux, Inc.
- Date Received
- January 11, 1983
- Decision Date
- February 9, 1983
- Product Code
- JSJ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JSJ | Culture Media, Selective And Non-Differential | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JSJ), ordered by most recent decision date.
POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421
FDA 510(k)
FDA Class 1
·Microbiology
INHIBITORY MOLD AGAR
FDA 510(k)
FDA Class 1
·Microbiology
YM BROTH
FDA 510(k)
FDA Class 1
·Microbiology
MITIS SALIVARIUS AGAR
FDA 510(k)
FDA Class 1
·Microbiology
W-L DIFFERENTIAL MEDIUM
FDA 510(k)
FDA Class 1
·Microbiology
LITTMAN AGAR
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by bioMerieux, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | Apr 15, 2026 | Substantially Equivalent |
| K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) | Aug 21, 2025 | Substantially Equivalent |
| K234012 | VITEK COMPACT PRO | Mar 14, 2025 | Substantially Equivalent |
| K232967 | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) | Jun 12, 2024 | Substantially Equivalent |
| K232963 | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) | Jun 7, 2024 | Substantially Equivalent |
| K240279 | VIDAS TBI (GFAP, UCH-L1) | May 1, 2024 | Substantially Equivalent |
| K234000 | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) | Mar 11, 2024 | Substantially Equivalent |
| K232201 | VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin | Oct 23, 2023 | Substantially Equivalent |
| K230864 | VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin | Jul 5, 2023 | Substantially Equivalent |
| K222378 | VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) | Jun 26, 2023 | Substantially Equivalent |