FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PORPHYRIN TEST AGAR
K Number: K840685
·
Decision Apr 17, 1984
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
86
Applicant Total
137
Review Days
62
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
- PORPHYRIN TEST AGAR
- K Number
- K840685
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Remel Co.
- Date Received
- February 15, 1984
- Decision Date
- April 17, 1984
- Product Code
- JSF
- 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 |
|---|---|---|---|
| JSF | Culture Media, Single Biochemical Test | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JSF), ordered by most recent decision date.
NUTRIENT GELATIN - PRODUCT NUMBER T2860
FDA 510(k)
FDA Class 1
·Microbiology
LAURYL TRYPTOSE BROTH
FDA 510(k)
FDA Class 1
·Microbiology
MOELLERS DECARBOXYLASE, ONITHINE
FDA 510(k)
FDA Class 1
·Microbiology
MOELLERS DECARBOXYLASE, LYSINE
FDA 510(k)
FDA Class 1
·Microbiology
CYSTINE TRYPTIC MEDIUM W/ MALTOSE
FDA 510(k)
FDA Class 1
·Microbiology
ACETAMIDE AGAR SLANT
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Remel Co.
| K Number | Device Name | ||
|---|---|---|---|
| K013711 | BACTI-SWAB DRY | Nov 26, 2001 | Substantially Equivalent |
| K965150 | A.C.T. IV | Jan 22, 1997 | Substantially Equivalent |
| K965151 | A.C.T. III | Jan 22, 1997 | Substantially Equivalent |
| K965152 | A.C.T. II | Jan 22, 1997 | Substantially Equivalent |
| K965149 | A.C.T. I | Jan 22, 1997 | Substantially Equivalent |
| K960090 | CALCOFLUOR WHITE STAIN KIT | Mar 19, 1996 | Substantially Equivalent |
| K960095 | BACTIDROP CALCOFLUOR WHITE | Mar 19, 1996 | Substantially Equivalent |
| K955669 | REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK | Feb 23, 1996 | Substantially Equivalent |
| K941443 | SYNERGY QUAD | Sep 19, 1994 | Substantially Equivalent |
| K941444 | BHI AGAR WITH VANCOMYCIN | Sep 19, 1994 | Substantially Equivalent |