Solution, Isotonic
An isotonic solution is a laboratory reagent used to maintain cells or biological specimens in an osmotic environment matching physiological conditions, used in hematology and pathology procedures for diluting and washing cell preparations without causing hemolysis or cell shrinkage. It is classified as FDA Class 1, the lowest risk designation, and is exempt from Good Manufacturing Practice requirements and premarket notification. The product code is JCE, regulated under 21 CFR 864.4010, within the Pathology medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- JCE
- Device Class
- FDA class 1
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K842722 | BUFFERED SALINE | Sep 11, 1984 | Substantially Equivalent | E K Ind., Inc. |
| K831200 | IMMUNOHEMATOLOGICAL SALINE #97139 | May 09, 1983 | Substantially Equivalent | Emd Chemicals, Inc. |
| K801506 | CERTIFIED BLOOD BANK SALINE | Jul 28, 1980 | Substantially Equivalent | Nobel Scientific Industries, Inc. |
| K792101 | COUITER/CMS ISOTONIC BLOOD BANK SALINE | Nov 20, 1979 | Substantially Equivalent | Coulter Electronics, Inc. |
| K761183 | LYSING AGENT AF | Jan 17, 1977 | Substantially Equivalent | Central Labs. Assoc. MD Pathologists |
| K761174 | PHYSIOLOGIC SALINE (0.85%) | Jan 10, 1977 | Substantially Equivalent | Bio/Data Corp. |
| K761170 | BARBITAL SALINE BUFFER | Jan 10, 1977 | Substantially Equivalent | Bio/Data Corp. |
FEI Numbers
This FDA classification entry is associated with 31 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 31 registration numbers. Click on an entry to view related FDA registrations.