Ats M/15 Phosphate Buffer, Product #034-42
FDA 510(k) K881879 · Alpha-Tec Systems, Inc.
510(k) numberK881879
Submission
- Device name
- Ats M/15 Phosphate Buffer, Product #034-42
- Applicant
- Alpha-Tec Systems, Inc.
Irvine, CA, US - Received
- May 4, 1988
- Decision date
- May 13, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSK – Supplement, Culture Media
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2450
- Specialty
- Microbiology
Other 510(k)s with product code JSK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881949 | Ats Nac-Pac SetJSK · Traditional | Alpha-Tec Systems, Inc. | 05/25/1988SE |
| K881566 | Hemoglobin PowderJSK · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K861997 | Penicillin-Streptomycin-Fungizone MixtureJSK · Traditional | Hazleton Research Products, Inc. | 06/10/1986SE |
| K861824 | Gentamicin Sulfate Solution (10MG Gentamicin)JSK · Traditional | Flow Laboratories, Inc. | 05/20/1986SE |
| K861823 | Gentamicin Sulfate Solution (50MG Gentamicin)JSK · Traditional | Flow Laboratories, Inc. | 05/20/1986SE |
| K861791 | Penicillin-Streptomycin-FungizoneJSK · Traditional | Flow Laboratories, Inc. | 05/20/1986SE |
| K855172 | Kwi (TM) G-Co/TwoJSK · Traditional | Micro-Bio-Logics | 02/20/1986SE |
| K853546 | Abbott Cation Supplement SolutionJSK · Traditional | Abbott Laboratories | 09/06/1985SE |
| K850302 | Suplex & Suplex DiluentJSK · Traditional | Pro-Lab, Inc. | 03/22/1985SE |
| K850738 | Supplement for Culture MediumJSK · Traditional | Roseville Medical Laboratoriesu | 03/20/1985SE |
More from Roseville Medical Laboratoriesu
| 510(k) | Device | Decision |
|---|---|---|
| K053257 | Para-Pro FC50LKS · Traditional | 05/12/2006SE |
| K890861 | Ats Dobell & O'Connor's IodineJTS · Traditional | 03/23/1989SE |
| K890020 | Ats Lugol's Iodine SolutionJTS · Traditional | 02/24/1989SE |
| K890148 | Ats TB Rapid Stain Set Product #034-45ICL · Traditional | 01/24/1989SE |
| K890022 | Ats Mayer's AlbuminKEL · Traditional | 01/10/1989SE |
| K883049 | Ats Para-Set Iodine Alcohol SolutionJTS · Traditional | 08/17/1988SE |
| K883048 | Ats Para-Set Modified Pva Fixative SolutionLDZ · Traditional | 08/17/1988SE |
| K883062 | Ats Schaudinn's Fixative W/Acetic AcidLDW · Traditional | 08/04/1988SE |
| K881949 | Ats Nac-Pac SetJSK · Traditional | 05/25/1988SE |
| K881698 | Ats Pva Fixative SolutionLDZ · Traditional | 05/13/1988SE |
Questions and answers
When was Ats M/15 Phosphate Buffer, Product #034-42 cleared by the FDA?
Ats M/15 Phosphate Buffer, Product #034-42 (K881879) received a 510(k) decision of Substantially Equivalent on May 13, 1988, 9 days after the submission was received.
What is the product code of K881879?
The FDA product code is JSK – Supplement, Culture Media, a Class I (low risk) device regulated under 21 CFR 866.2450.