FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BACTOGEN-H. INFLUENZAE TYPE B
K Number: K800493
·
Decision Apr 4, 1980
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
68
Review Days
31
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Basic Information
- Device Name
- BACTOGEN-H. INFLUENZAE TYPE B
- K Number
- K800493
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3300
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Armkel, LLC
- Date Received
- March 4, 1980
- Decision Date
- April 4, 1980
- Product Code
- GRO
- 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 |
|---|---|---|---|
| GRO | Antisera, Fluorescent, All Types, Hemophilus Spp. | FDA class 2 | Microbiology |
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|---|---|---|---|
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| K013433 | TROJAN PASSION BERRY GEL | Mar 5, 2002 | Substantially Equivalent |
| K013614 | TROJAN CRYSTAL CLEAR LIQUID | Feb 1, 2002 | Substantially Equivalent |
| K001212 | TROJAN EXTRA LARGE LATEX CONDOM | May 9, 2000 | Substantially Equivalent |
| K000748 | TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT | Apr 6, 2000 | Substantially Equivalent |
| K992232 | FIRST RESPONSE 1-STEP PREGNANCY | Dec 21, 1999 | Substantially Equivalent |
| K973352 | BRAND NAME *1-STEP PREGNANCY | Oct 27, 1997 | Substantially Equivalent |
| K973310 | TBD* ONE-STEP OVULATION PREDICTOR TEST | Oct 27, 1997 | Substantially Equivalent |