FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRYPTICASE SOY BROTH BLOOD CULTURE BOTT
K Number: K812335
·
Decision Sep 9, 1981
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
51
Applicant Total
89
Review Days
22
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Basic Information
- Device Name
- TRYPTICASE SOY BROTH BLOOD CULTURE BOTT
- K Number
- K812335
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2350
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Fisher Scientific Co., LLC
- Date Received
- August 18, 1981
- Decision Date
- September 9, 1981
- Product Code
- JSC
- 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 |
|---|---|---|---|
| JSC | Culture Media, General Nutrient Broth | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JSC), ordered by most recent decision date.
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SABOURAUD BHI AGAR
FDA 510(k)
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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 |