Hemoglobin Powder
FDA 510(k) K881566 · Acumedia Manufacturers, Inc.
510(k) numberK881566
Submission
- Device name
- Hemoglobin Powder
- Applicant
- Acumedia Manufacturers, Inc.
Baltimore, MD, US - Received
- April 11, 1988
- Decision date
- April 18, 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
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| K881949 | Ats Nac-Pac SetJSK · Traditional | Alpha-Tec Systems, Inc. | 05/25/1988SE |
| K881879 | Ats M/15 Phosphate Buffer, Product #034-42JSK · Traditional | Alpha-Tec Systems, Inc. | 05/13/1988SE |
| 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 |
|---|---|---|
| K881579 | Amies Transport Medium W/O CharcoalJSN · Traditional | 04/18/1988SE |
| K881578 | StreptoselJSJ · Traditional | 04/18/1988SE |
| K881577 | Modified Selective Streptococcus AgarJSI · Traditional | 04/18/1988SE |
| K881576 | Selenite BrothJSI · Traditional | 04/18/1988SE |
| K881575 | Selective Streptococcus AgarJSI · Traditional | 04/18/1988SE |
| K881574 | W-L Differential MediumJSJ · Traditional | 04/18/1988SE |
| K881573 | Phytone Yeast Extract AgarJSJ · Traditional | 04/18/1988SE |
| K881572 | XL Agar BaseJSI · Traditional | 04/18/1988SE |
| K881571 | Ym BrothJSJ · Traditional | 04/18/1988SE |
| K881570 | Sabouraud Maltose AgarJSJ · Traditional | 04/18/1988SE |
Questions and answers
When was Hemoglobin Powder cleared by the FDA?
Hemoglobin Powder (K881566) received a 510(k) decision of Substantially Equivalent on April 18, 1988, 7 days after the submission was received.
What is the product code of K881566?
The FDA product code is JSK – Supplement, Culture Media, a Class I (low risk) device regulated under 21 CFR 866.2450.