Hepes Buffer Im in Normal Saline
FDA 510(k) K844877 · Hazleton Research Products, Inc.
510(k) numberK844877
Submission
- Device name
- Hepes Buffer Im in Normal Saline
- Applicant
- Hazleton Research Products, Inc.
Denver, PA, US - Received
- December 17, 1984
- Decision date
- February 25, 1985
- 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 |
| K842725 | Saline, 0.85%W/PRESERVATIVEKIP · Traditional | E K Ind., Inc. | 08/03/1984SE |
| 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 |
|---|---|---|
| K861997 | Penicillin-Streptomycin-Fungizone MixtureJSK · Traditional | 06/10/1986SE |
| K861996 | Dulbecco's Mem with 4.5 G/L Glucose MediumKIT · Traditional | 06/09/1986SE |
| K861887 | Mem Glasgow Powdered MediumKIT · Traditional | 05/29/1986SE |
| K861886 | Dmem & Ham's F-12 (1:1) Powdered MediumKIT · Traditional | 05/29/1986SE |
| K861885 | Williams Medium E PowderKIT · Traditional | 05/29/1986SE |
| K861875 | RPMI-1640 Medium with 25MM Hepes BufferKIT · Traditional | 05/29/1986SE |
| K861874 | Minimum Essential Med. (Eagle) W/25MM Hepes BufferKIT · Traditional | 05/29/1986SE |
| K861873 | Mem Glasgow MediumKIT · Traditional | 05/29/1986SE |
| K861872 | Iscove's (Modified) Dulbecco's MediumKIT · Traditional | 05/29/1986SE |
| K861871 | NCTC 109 MediumKIT · Traditional | 05/29/1986SE |
Questions and answers
When was Hepes Buffer Im in Normal Saline cleared by the FDA?
Hepes Buffer Im in Normal Saline (K844877) received a 510(k) decision of Substantially Equivalent on February 25, 1985, 70 days after the submission was received.
What is the product code of K844877?
The FDA product code is KIP – Formulations, Balanced Salt Solutions, a Class I (low risk) device regulated under 21 CFR 864.2875.