FDA 510(k)
Substantially Equivalent
🇺🇸 United States
MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM
K Number: K875181
·
Decision May 27, 1988
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
38
Review Days
162
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Basic Information
- Device Name
- MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM
- K Number
- K875181
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Marion Laboratories, Inc.
- Date Received
- December 17, 1987
- Decision Date
- May 27, 1988
- Advisory Committee
- Unknown
- Review Advisory Committee
- TX
- Third Party
- N
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 |
| 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 |
| K853073 | CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D. | Aug 1, 1985 | Substantially Equivalent |