FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE
K Number: K862123
·
Decision Jun 16, 1986
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
17
Applicant Total
38
Review Days
13
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Basic Information
- Device Name
- BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE
- K Number
- K862123
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2580
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Marion Laboratories, Inc.
- Date Received
- June 3, 1986
- Decision Date
- June 16, 1986
- Product Code
- KZJ
- 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 |
|---|---|---|---|
| KZJ | Device, Gas Generating | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KZJ), ordered by most recent decision date.
BREWER GEL FOR CAMPYLOBACTER
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BREWER GEL FOR ANAEROBES
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BBL(R) GASPAK CO2 POUCH(TM)
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ANAEROBIC TRANSPORT POUCH (CATALYST-FREE)
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ANABAG
FDA 510(k)
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BBL CAMPY POUCH
FDA 510(k)
FDA Class 1
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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 |
| K853073 | CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D. | Aug 1, 1985 | Substantially Equivalent |