Erma Hb-Meter Model 303N
FDA 510(k) K854687 · Future Impex Corp.
510(k) numberK854687
Submission
- Device name
- Erma Hb-Meter Model 303N
- Applicant
- Future Impex Corp.
Deerpark, NY, US - Received
- November 20, 1985
- Decision date
- June 4, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KHG – Whole Blood Hemoglobin Determination
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7500
- Specialty
- Hematology
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|---|---|---|---|
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| K163215 | AnemoCheckKHG · Traditional | Sanguina, LLC | 09/13/2017SE |
| K042379 | Anemiapro Self-ScreenerKHG · Traditional | Biosafe Laboratories, Inc. | 12/15/2004SE |
| K020138 | Stat-Site MHGB Meter, Stat-Site MHGB Meter Card Holder, Stat-Site MHGB Test Cards…KHG · Special | Gds Technology | 02/11/2002SE |
| K001462 | Careside HemoglobinKHG · Traditional | Careside, Inc. | 08/21/2000SE |
| K994073 | Hemosite Test SystemKHG · Traditional | Gds Technology, LLC | 01/14/2000SE |
| K973649 | Hemosite Test SystemKHG · Traditional | Gds Technology, LLC | 08/31/1998SE |
| K953221 | Abbott Vision Hemoglobin (Modification)KHG · Traditional | Abbott Laboratories | 09/29/1995SE |
| K934064 | Reflotron Hemoglobin Test TabsKHG · Traditional | Boehringer Mannheim Corp. | 12/06/1993SE |
| K895101 | Biotrack Hemoglobin Test CartridgeKHG · Traditional | Biotrack, Inc. | 10/10/1989SE |
More from Biotrack, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K861487 | ST-90 Spiro AnalizerBTY · Traditional | 06/23/1986SE |
| K854686 | TE-25 Coaguro MeterJBP · Traditional | 06/04/1986SE |
| K854685 | DIGITAL-9 Key Leucocyte CounterGKM · Traditional | 04/04/1986SE |
| K854678 | Erma PC-602 PC-603 Blood Cell CounterGKL · Traditional | 02/24/1986SE |
| K854677 | Erma PC-604 Blood Cell CounterGKL · Traditional | 02/24/1986SE |
| K854679 | PHOTIC-100 SpectrophotometerJJQ · Traditional | 02/20/1986SE |
| K843934 | Model {M-102 I-Channel Electro Cardiograph UnitDPS · Traditional | 11/20/1984SE |
| K843984 | PM-80 PulmotesterBZG · Traditional | 10/24/1984SE |
| K843700 | ST-200A W/Maximal Voluntary Ventillat- · Traditional | 10/24/1984SE |
| K832433 | Automatic Spirometer ST-200BZG · Traditional | 09/29/1983SE |
Questions and answers
When was Erma Hb-Meter Model 303N cleared by the FDA?
Erma Hb-Meter Model 303N (K854687) received a 510(k) decision of Substantially Equivalent on June 4, 1986, 196 days after the submission was received.
What is the product code of K854687?
The FDA product code is KHG – Whole Blood Hemoglobin Determination, a Class II (moderate risk) device regulated under 21 CFR 864.7500.