Saline, 0.85%W/PRESERVATIVE
FDA 510(k) K842725 · E K Ind., Inc.
510(k) numberK842725
Submission
- Device name
- Saline, 0.85%W/PRESERVATIVE
- Applicant
- E K Ind., Inc.
Mchenry, IL, US - Received
- July 13, 1984
- Decision date
- August 3, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KIP – Formulations, Balanced Salt Solutions
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.2875
- Specialty
- Hematology
Other 510(k)s with product code KIP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K870491 | Krebs-Ringer Bicarbonate Buffer Product No. K4002KIP · Traditional | Sigma Chemical Co. | 03/30/1987SE |
| K870486 | Earle's Balanced Salts (Ebss) Hybri-Max #E9509KIP · Traditional | Sigma Chemical Co. | 03/30/1987SE |
| K870484 | Hanks' Balanced Salts (HBSS) No. H1387KIP · Traditional | Sigma Chemical Co. | 03/30/1987SE |
| K870482 | (D-Pbs) Modified Hybri-Max Product No. D7030KIP · Traditional | Sigma Chemical Co. | 03/30/1987SE |
| K860784 | Dulbecco's Phosphate Buffered Saline W/CALCL2KIP · Traditional | Tissue Culture Innovations | 03/12/1986SE |
| K844878 | Trypsin 10X - 1:250 in HBSS W/O Ca & MGKIP · Traditional | Hazleton Research Products, Inc. | 02/25/1985SE |
| K844877 | Hepes Buffer Im in Normal SalineKIP · Traditional | Hazleton Research Products, Inc. | 02/25/1985SE |
| K842724 | Saline 0.85% W/O PreservativeKIP · Traditional | E K Ind., Inc. | 08/03/1984SE |
| K842723 | Saline, 1.3% W/O PreservativeKIP · Traditional | E K Ind., Inc. | 08/03/1984SE |
| K820928 | Ebs PowderKIP · Traditional | Dutchland Laboratories, Inc. | 04/21/1982SE |
More from Dutchland Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K842931 | Drabkin ReagentKAG · Traditional | 09/21/1984SE |
| K842938 | Acetic Acid 1% V/VGGK · Traditional | 09/14/1984SE |
| K842937 | Acetic Acid 2% V/VGGK · Traditional | 09/12/1984SE |
| K842936 | Acetic Acid, 3% V/VGGK · Traditional | 09/12/1984SE |
| K842935 | Acetic Acid, 5% V/VGGK · Traditional | 09/12/1984SE |
| K842934 | Decolorizing Fluic, Acid-Alcohol 3%PPM · Traditional | 09/12/1984SE |
| K842933 | Carbol-Fuchsin, Ziehl-NeedsenICL · Traditional | 09/11/1984SE |
| K842930 | Gomori's Trichrome StainLED · Traditional | 09/11/1984SE |
| K842928 | Jenner Blood StainKJX · Traditional | 09/11/1984SE |
| K842927 | Light Green SF 1%HYS · Traditional | 09/11/1984SE |
Questions and answers
When was Saline, 0.85%W/PRESERVATIVE cleared by the FDA?
Saline, 0.85%W/PRESERVATIVE (K842725) received a 510(k) decision of Substantially Equivalent on August 3, 1984, 21 days after the submission was received.
What is the product code of K842725?
The FDA product code is KIP – Formulations, Balanced Salt Solutions, a Class I (low risk) device regulated under 21 CFR 864.2875.