FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GRAM STAIN KIT
K Number: K853896
·
Decision Oct 22, 1985
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
39
Applicant Total
164
Review Days
32
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
- GRAM STAIN KIT
- K Number
- K853896
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Sigma Diagnostics, Inc.
- Date Received
- September 20, 1985
- Decision Date
- October 22, 1985
- Product Code
- JTS
- 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 |
|---|---|---|---|
| JTS | Stains, Microbiologic | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JTS), ordered by most recent decision date.
CALCOFLUOR WHITE STAIN KIT
FDA 510(k)
FDA Class 1
·Hematology
BACTIDROP CALCOFLUOR WHITE
FDA 510(k)
FDA Class 1
·Hematology
BACTIDROP KOH (10%)
FDA 510(k)
FDA Class 1
·Hematology
BACTIDROP INDIA INK
FDA 510(k)
FDA Class 1
·Hematology
BACTIDROP CALCOFLUOR WHITE
FDA 510(k)
FDA Class 1
·Hematology
IRISTAIN FORMULA 2, PARTS 1 AND 2
FDA 510(k)
FDA Class 1
·Hematology
Other Clearances by Sigma Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K021162 | AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED | Aug 30, 2002 | Substantially Equivalent |
| K020109 | SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL | Feb 6, 2002 | Substantially Equivalent |
| K013549 | SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 | Dec 26, 2001 | Substantially Equivalent |
| K013544 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 | Nov 15, 2001 | Substantially Equivalent |
| K013545 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 | Nov 15, 2001 | Substantially Equivalent |
| K012410 | INFINITY HBA KIT, MODELS 537-A, 537-B | Oct 26, 2001 | Substantially Equivalent |
| K010652 | SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 | Mar 30, 2001 | Substantially Equivalent |
| K010158 | THROMBOMAX-HS WITH CALCIUM, MODEL T6540 | Mar 22, 2001 | Substantially Equivalent |
| K003267 | SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A | Mar 15, 2001 | Substantially Equivalent |
| K003329 | SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 | Mar 1, 2001 | Substantially Equivalent |