FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PHOSPHATE BUFFERED SALINE (1X)
K Number: K811791
·
Decision Aug 25, 1981
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
6
Applicant Total
75
Review Days
62
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Basic Information
- Device Name
- PHOSPHATE BUFFERED SALINE (1X)
- K Number
- K811791
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Dutchland Laboratories, Inc.
- Date Received
- June 24, 1981
- Decision Date
- August 25, 1981
- Product Code
- JCC
- Advisory Committee
- Pathology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JCC | Ph Buffer | FDA class 1 | Pathology |
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Other Clearances by Dutchland Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K821913 | ISCOVE'S MODIFIED DULBECCO POWDER MEDIUM | Jul 27, 1982 | Substantially Equivalent |
| K821912 | MCCOY'S POWDER MEDIUM 5A SUSPENSION | Jul 27, 1982 | Substantially Equivalent |
| K821918 | POWDERED RPMI-1603 MEDIUM | Jul 27, 1982 | Substantially Equivalent |
| K821917 | WAYMOUTH'S POWDER MEDIUM | Jul 27, 1982 | Substantially Equivalent |
| K821916 | IMPROVED MEM-RICHTER'S POWDER MODIF. | Jul 27, 1982 | Substantially Equivalent |
| K821919 | POWDERED RPMI-1634 MEDIUM | Jul 27, 1982 | Substantially Equivalent |
| K821911 | S-MEM-JOKLIK'S POWDER | Jul 27, 1982 | Substantially Equivalent |
| K821914 | COON'S F-12 POWDER MEDIUM | Jul 27, 1982 | Substantially Equivalent |
| K821915 | BME AUTOCLAVABLE MEDIUM | Jul 27, 1982 | Substantially Equivalent |
| K820926 | E-BME POWDERED MEDIUM | Apr 21, 1982 | Substantially Equivalent |