FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
#2007 XLD
K Number: K820801
·
Decision Apr 8, 1982
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
284
Applicant Total
19
Review Days
16
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
- #2007 XLD
- K Number
- K820801
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Biomedica, Inc.
- Date Received
- March 23, 1982
- Decision Date
- April 8, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JSI), ordered by most recent decision date.
BBL CHROMAGAR 0157
FDA 510(k)
FDA Class 1
·Microbiology
DIPSTREAK
FDA 510(k)
FDA Class 1
·Microbiology
LISTERIA SELECTIVE ENRICHMENT MEDIUM
FDA 510(k)
FDA Class 1
·Microbiology
DENTOCULT SM-STRIP MUTANS
FDA 510(k)
FDA Class 1
·Microbiology
SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326
FDA 510(k)
FDA Class 1
·Microbiology
MODIFIED SELECTIVE STREPTOCOCCUS AGAR
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Biomedica, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K820792 | #19041-150X15MM MUELLER HINTON | Apr 8, 1982 | Substantially Equivalent |
| K820798 | #2001 HEKTOEN | Apr 8, 1982 | Substantially Equivalent |
| K820797 | #50001 QUADE DIAGNOSTIC SYSTEM | Apr 8, 1982 | Substantially Equivalent |
| K820806 | #2004 PHENYLETHYL ALCHOL AGAR W/SHEEP BL | Apr 8, 1982 | Substantially Equivalent |
| K820795 | #4006 TSB-TUBED MEDIA | Apr 8, 1982 | Substantially Equivalent |
| K820807 | #2011 STREP SELECTIVE AGAR | Apr 8, 1982 | Substantially Equivalent |
| K820804 | #2013 CNA 5% SHEEP BLOOD | Apr 8, 1982 | Substantially Equivalent |
| K820800 | #2006 SALMONELLA SHIGELLA AGAR | Apr 8, 1982 | Substantially Equivalent |
| K820802 | #2009 BIGGY AGAR | Apr 8, 1982 | Substantially Equivalent |
| K820810 | #4004 TRIPLE SUGAR IRON AGAR SLANTS-TUBE | Apr 8, 1982 | Substantially Equivalent |