FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GRAM IODINE
K Number: K871286
·
Decision Apr 8, 1987
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
5
Applicant Total
137
Review Days
8
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Basic Information
- Device Name
- GRAM IODINE
- K Number
- K871286
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Remel Co.
- Date Received
- March 31, 1987
- Decision Date
- April 8, 1987
- Product Code
- HYI
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| HYI | Iodine, Grams | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HYI), ordered by most recent decision date.
GRAM IODINE
FDA 510(k)
FDA Class 1
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GRAMSTAIN SET
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FDA Class 1
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PARA-PAK
FDA 510(k)
FDA Class 1
·Hematology
IMPROVED GRAM STAIN REAGENTS
FDA 510(k)
FDA Class 1
·Hematology
GRAM STAIN KIT
FDA 510(k)
FDA Class 1
·Hematology
Other Clearances by Remel Co.
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|---|---|---|---|
| K013711 | BACTI-SWAB DRY | Nov 26, 2001 | Substantially Equivalent |
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| 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 |