The following data is part of a premarket notification filed by I-stat Corp. with the FDA for I-stat Lactate Test.
| Device ID | K982071 |
| 510k Number | K982071 |
| Device Name: | I-STAT LACTATE TEST |
| Classification | Acid, Lactic, Enzymatic Method |
| Applicant | I-STAT CORP. 303 COLLEGE RD. EAST Princeton, NJ 08540 |
| Contact | Paul Vandrwerf |
| Correspondent | Paul Vandrwerf I-STAT CORP. 303 COLLEGE RD. EAST Princeton, NJ 08540 |
| Product Code | KHP |
| CFR Regulation Number | 862.1450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-12 |
| Decision Date | 1998-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10054749000132 | K982071 | 000 |