FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BACTIDROP(TM) LACTOPHENOL ANILINE BLUE
K Number: K913005
·
Decision Sep 16, 1991
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
10
Applicant Total
137
Review Days
70
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Basic Information
- Device Name
- BACTIDROP(TM) LACTOPHENOL ANILINE BLUE
- K Number
- K913005
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6550
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Remel Co.
- Date Received
- July 8, 1991
- Decision Date
- September 16, 1991
- Product Code
- JIO
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| JIO | Blood, Occult, Colorimetric, In Urine | FDA class 2 | Hematology |
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Other Clearances by Remel Co.
| K Number | Device Name | ||
|---|---|---|---|
| K013711 | BACTI-SWAB DRY | Nov 26, 2001 | Substantially Equivalent |
| K965150 | A.C.T. IV | Jan 22, 1997 | Substantially Equivalent |
| K965151 | A.C.T. III | Jan 22, 1997 | Substantially Equivalent |
| K965152 | A.C.T. II | Jan 22, 1997 | Substantially Equivalent |
| K965149 | A.C.T. I | Jan 22, 1997 | Substantially Equivalent |
| K960090 | CALCOFLUOR WHITE STAIN KIT | Mar 19, 1996 | Substantially Equivalent |
| K960095 | BACTIDROP CALCOFLUOR WHITE | Mar 19, 1996 | Substantially Equivalent |
| K955669 | REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK | Feb 23, 1996 | Substantially Equivalent |
| K941443 | SYNERGY QUAD | Sep 19, 1994 | Substantially Equivalent |
| K941444 | BHI AGAR WITH VANCOMYCIN | Sep 19, 1994 | Substantially Equivalent |