FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI
K Number: K852044
·
Decision Jul 19, 1985
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
41
Applicant Total
38
Review Days
71
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
- CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI
- K Number
- K852044
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Marion Laboratories, Inc.
- Date Received
- May 9, 1985
- Decision Date
- July 19, 1985
- Product Code
- LLH
- 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 |
|---|---|---|---|
| LLH | Reagents, Clostridium Difficile Toxin | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLH), ordered by most recent decision date.
SensiTox C. difficile Toxin Test
FDA 510(k)
FDA Class 1
·Microbiology
OSOM C. DIFFICILE TOXIN A/B TEST
FDA 510(k)
FDA Class 1
·Microbiology
XPERT C. DIFFICILE
FDA 510(k)
FDA Class 1
·Microbiology
PROGASTRO CD ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
C. DIFF QUIK CHEK COMPLETE
FDA 510(k)
FDA Class 1
·Microbiology
BD GENEOHM CDIFF ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Marion Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883391 | POLYMER ADHESIVE BANDAGE | Mar 23, 1989 | Substantially Equivalent for Some Indications |
| K875182 | MODIFIED LABELING FOR TOXI-LAB THC SCREEN | Jul 5, 1988 | Substantially Equivalent |
| K875181 | MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM | May 27, 1988 | Substantially Equivalent |
| K874554 | ENVICLUSIVE (TM) | Mar 11, 1988 | Substantially Equivalent |
| K874551 | ENVINET(TM) | Jan 22, 1988 | Substantially Equivalent for Some Indications |
| K874552 | ENVISAN PAD | Jan 22, 1988 | Substantially Equivalent for Some Indications |
| K874553 | ENVISAN PASTE | Dec 18, 1987 | Substantially Equivalent for Some Indications |
| K870864 | CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST | Apr 14, 1987 | Substantially Equivalent |
| K863485 | MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST | Sep 17, 1986 | Substantially Equivalent |
| K862123 | BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE | Jun 16, 1986 | Substantially Equivalent |