FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPOTTEST CALCOFLUOR WHITE REAGENT
K Number: K860795
·
Decision Mar 12, 1986
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
15
Applicant Total
121
Review Days
8
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Basic Information
- Device Name
- SPOTTEST CALCOFLUOR WHITE REAGENT
- K Number
- K860795
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Difco Laboratories, Inc.
- Date Received
- March 4, 1986
- Decision Date
- March 12, 1986
- Product Code
- LED
- 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 |
|---|---|---|---|
| LED | Stains, Chemical Solution | FDA class 1 | Hematology |
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Other Clearances by Difco Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K971211 | DISPENS-O-DISC SPARFLOXACIN | Apr 14, 1997 | Substantially Equivalent |
| K971120 | DISPENS-O-DISC (TM) LEVOFLOXACIN | Apr 14, 1997 | Substantially Equivalent |
| K963508 | DISPENS-O-DISC MEROPENEM | Sep 26, 1996 | Substantially Equivalent |
| K961148 | CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG) | Apr 26, 1996 | Substantially Equivalent |
| K954783 | DRYSLIDE CARTARRHALIS | Feb 6, 1996 | Substantially Equivalent |
| K954784 | DRYSIDE NEISSERIA | Jan 30, 1996 | Substantially Equivalent |
| K953129 | ESP CULTURE SYSTEM - MYCO | Dec 26, 1995 | Substantially Equivalent |
| K950706 | DRYSLIDE COAGULASE | May 16, 1995 | Substantially Equivalent |
| K944275 | DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG. | Dec 19, 1994 | Substantially Equivalent |
| K941016 | DISPENS-O-DISC(TM) NITROCEFIN | Jun 30, 1994 | Substantially Equivalent |