FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEMATOLOGY STAIN PACK
K Number: K853241
·
Decision Aug 19, 1985
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
32
Applicant Total
89
Review Days
18
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HEMATOLOGY STAIN PACK
- K Number
- K853241
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Fisher Scientific Co., LLC
- Date Received
- August 1, 1985
- Decision Date
- August 19, 1985
- Product Code
- IAF
- 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 |
|---|---|---|---|
| IAF | Wright'S Stain | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IAF), ordered by most recent decision date.
WRIGHT-GLEMSA STAIN
FDA 510(k)
FDA Class 1
·Hematology
ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET
FDA 510(k)
FDA Class 1
·Hematology
HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS
FDA 510(k)
FDA Class 1
·Hematology
CAMCO STAIN PAK
FDA 510(k)
FDA Class 1
·Hematology
WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S
FDA 510(k)
FDA Class 1
·Hematology
WRIGHT STAIN
FDA 510(k)
FDA Class 1
·Hematology
Other Clearances by Fisher Scientific Co., LLC
| K Number | Device Name | ||
|---|---|---|---|
| K930415 | MICROHEMATOCRIT ROTOR | Mar 23, 1993 | Substantially Equivalent |
| K915825 | MARATHON 6K GENERAL-PURPOSE CENTRIFUGE | Mar 11, 1992 | Substantially Equivalent |
| K915441 | MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE | Jan 8, 1992 | Substantially Equivalent |
| K890534 | MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 | Mar 8, 1989 | Substantially Equivalent |
| K881275 | URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II | May 16, 1988 | Substantially Equivalent |
| K874054 | FISHER DIAGNOSTICS HEMATALL III LAS REAGENT | Oct 20, 1987 | Substantially Equivalent |
| K872916 | HISTOMATIC SLIDE STAINER, CODE-ON VERSION | Sep 14, 1987 | Substantially Equivalent |
| K871058 | SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN) | Apr 6, 1987 | Substantially Equivalent |
| K863224 | HEMATALL-C PLUS HEMATOLOGY CONTROLS | Oct 29, 1986 | Substantially Equivalent |
| K862318 | FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR | Jul 10, 1986 | Substantially Equivalent |