FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GIBCO MYCOTECT KIT (CATALOG NO. 189-5672)
K Number: K860695
·
Decision Mar 12, 1986
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
1
Applicant Total
67
Review Days
15
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Basic Information
- Device Name
- GIBCO MYCOTECT KIT (CATALOG NO. 189-5672)
- K Number
- K860695
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2360
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Gibco Laboratories Life Technologies, Inc.
- Date Received
- February 25, 1986
- Decision Date
- March 12, 1986
- Product Code
- KIW
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| KIW | Kit, Mycoplasma Detection | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KIW), ordered by most recent decision date.
View allOther Clearances by Gibco Laboratories Life Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K871855 | SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORM | May 26, 1987 | Substantially Equivalent |
| K871541 | MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226 | Apr 29, 1987 | Substantially Equivalent |
| K870134 | MCBRIDE LISTERIA AGAR W/CYCLOHEXIMIDE, DRI & PRE | Feb 4, 1987 | Substantially Equivalent |
| K864755 | PSEUDOMONAS CEPACIA SELECTIVE AGAR, DRI & PRE-FORM | Jan 5, 1987 | Substantially Equivalent |
| K864014 | LOMBARD DOWELL AGAR BASE | Oct 29, 1986 | Substantially Equivalent |
| K863821 | MUELLER HINTON AGAR W/4%NACL AND OXACILLIN | Oct 9, 1986 | Substantially Equivalent |
| K863820 | DRI-FORM: GBNA LISTERIA MEDIUM NO. M22300 | Oct 8, 1986 | Substantially Equivalent |
| K863289 | CDC ANAEROBIC AGAR W/SHEEP BLOOD, KANA-&VANCOMYCIN | Sep 3, 1986 | Substantially Equivalent |
| K862425 | MACCONKEY AGAR W/MUG, DRI-FORM AND PRE-FORM | Jul 2, 1986 | Substantially Equivalent |
| K861058 | SENSITITRE AUTO ID PLATE, AP70 | May 20, 1986 | Substantially Equivalent |