FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EARLE'S BALANCED SALTS SOULTION
K Number: K810779
·
Decision May 13, 1981
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
16
Applicant Total
75
Review Days
51
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Basic Information
- Device Name
- EARLE'S BALANCED SALTS SOULTION
- K Number
- K810779
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2875
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Dutchland Laboratories, Inc.
- Date Received
- March 23, 1981
- Decision Date
- May 13, 1981
- Product Code
- KIP
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| KIP | Formulations, Balanced Salt Solutions | FDA class 1 | Hematology |
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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 |