FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL
K Number: K961042
·
Decision May 30, 1996
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
3
Applicant Total
40
Review Days
77
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Basic Information
- Device Name
- MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL
- K Number
- K961042
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Microscan, Inc.
- Date Received
- March 14, 1996
- Decision Date
- May 30, 1996
- Product Code
- LRH
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| LRH | Instrument For Auto Reader Of Overnight Microorganism Identification System | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRH), ordered by most recent decision date.
GRAM NEGATIVE IDENTIFICATION PLUS CARD
FDA 510(k)
FDA Class 1
·Microbiology
READER
FDA 510(k)
FDA Class 1
·Microbiology
AUTOSCEPTOR IDENTIFICATION SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Dade Microscan, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K043589 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM | Feb 14, 2005 | Substantially Equivalent |
| K023202 | MICROSCAN SYNERGIES PLUS | Oct 23, 2002 | Substantially Equivalent |
| K021184 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN | Jun 20, 2002 | Substantially Equivalent |
| K021181 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN | Jun 17, 2002 | Substantially Equivalent |
| K021018 | MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL | Jun 11, 2002 | Substantially Equivalent |
| K021188 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME | Jun 6, 2002 | Substantially Equivalent |
| K021169 | MICROSTREP PLUS PANEL, AZITHROMYCIN | Jun 6, 2002 | Substantially Equivalent |
| K021111 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME | Jun 6, 2002 | Substantially Equivalent |
| K021078 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN | Jun 6, 2002 | Substantially Equivalent |
| K021110 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE | Jun 6, 2002 | Substantially Equivalent |