(D-Pbs) Modified Hybri-Max Product No. D7030
FDA 510(k) K870482 · Sigma Chemical Co.
510(k) numberK870482
Submission
- Device name
- (D-Pbs) Modified Hybri-Max Product No. D7030
- Applicant
- Sigma Chemical Co.
St. Louis, MO, US - Received
- February 3, 1987
- Decision date
- March 30, 1987
- 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 |
| 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 |
| 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 |
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| K933692 | Sigma CO2 Acid ReagentJFL · Traditional | 12/09/1993SE |
| K933695 | Sigma Electrolyte BufferJFL · Traditional | 10/22/1993SE |
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Questions and answers
When was (D-Pbs) Modified Hybri-Max Product No. D7030 cleared by the FDA?
(D-Pbs) Modified Hybri-Max Product No. D7030 (K870482) received a 510(k) decision of Substantially Equivalent on March 30, 1987, 55 days after the submission was received.
What is the product code of K870482?
The FDA product code is KIP – Formulations, Balanced Salt Solutions, a Class I (low risk) device regulated under 21 CFR 864.2875.